Effects of a Novel Erectogenic Condom on Men and Women's Sexual Pleasure: Randomized Controlled Trial.

We tested whether CSD500 (Futura Medical; Guildford, UK), a novel condom containing erectogenic gel designed to increase penile firmness, penile size, and erection duration, results in greater sexual pleasure. In 2017-2020, we randomized heterosexual couples in Thanh Hoa, Vietnam to use CSD500 (N = 248) or standard condoms (N = 252) and followed them up for six months. Women completed the Quality of Sexual Experience (QSE) scale; men completed the QSE, Sexual Experience Questionnaire (SEX-Q), and 11 condom acceptability items. Female participants' mean age was 32.1 years (SD = 0.24; range 21-46). QSE scores were higher among women (B, 0.12; 95% CI, 0.03-0.21) and men (B, 0.21; 95% CI, 0.08-0.35) in the CSD500 relative to the control arm. SEX-Q scores were higher among men in the CSD500 compared to the control arm (B, 3.22; 95% CI, 1.53-4.91). Higher proportions of men in the CSD500 relative to the control arm reported the condom felt "natural" during sex (68.6% vs. 32.3%; p < .01) and that sex with the condom felt "a lot better" than condomless sex (15.5% vs. 5.3%; p < .01). Compared with standard condoms, CSD500 use was associated with higher reports of sexual pleasure and condom acceptability.

Skin patch and vaginal ring versus combined oral contraceptives for contraception.

BACKGROUND: The delivery of combination contraceptive steroids from a skin patch or vaginal ring offers potential advantages over the traditional oral route. The skin patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance. OBJECTIVES: To compare the contraceptive effectiveness, cycle control, compliance, and safety of the skin patch or the vaginal ring versus combination oral contraceptives (COCs). SEARCH STRATEGY: We searched MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS for trials of the contraceptive patch or the vaginal ring. We contacted manufacturers and researchers to identify other trials. SELECTION CRITERIA: All randomized controlled trials comparing the skin patch or vaginal ring with a COC. DATA COLLECTION AND ANALYSIS: Data were abstracted by two authors and entered into RevMan. For dichotomous variables, the Peto odds ratio (OR) with 95% confidence intervals (CI) was calculated. For continuous variables, the weighted mean difference was computed. MAIN RESULTS: We found three trials of the skin patch and eight of the vaginal ring. Contraceptive effectiveness was similar for the patch or ring and the comparison COC. Patch users reported more compliant cycles than COC users; ORs were 2.05 (95% CI 1.83 to 2.29) and 2.76 (95% CI 2.35 to 3.24) in two trials. One crossover ring trial had more noncompliance for the ring users. Satisfaction with method was higher for ring users than COC users in two studies. More patch users discontinued early than COC users: OR 1.58 (95% CI 1.25 to 1.99) and 1.45 (95% CI 1.11 to 1.90) in two trials. Patch users also had more discontinuation due to adverse events (AEs). The ring trials generally showed similar discontinuation for ring and COC users. Compared to COC users, patch users were more likely to report breast discomfort, dysmenorrhea, nausea, and vomiting. Ring users reported less nausea, irritability, and depression than COC users in single trials. However, ring users had more vaginitis and leukorrhea. Bleeding problems were generally similar or less common for the ring versus COC. AUTHORS' CONCLUSIONS: Effectiveness rates were similar for the methods compared. The patch group had better compliance than the COC group. Compared to COC users, patch users had more side effects. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge. The patch could lead to more discontinuation while the vaginal ring showed little difference. High losses to follow up can affect the validity of the results.

Vasectomy occlusion techniques for male sterilization.

BACKGROUND: Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including various vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), as well as vasectomy with vas irrigation or with fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the best available evidence from randomized controlled trials. OBJECTIVES: The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization. SEARCH STRATEGY: We searched the computerized databases of CENTRAL, MEDLINE, EMBASE, POPLINE and LILACS. In addition, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: We included randomized controlled trials comparing vasectomy techniques. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches. Two reviewers independently extracted data from articles identified for inclusion. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. MAIN RESULTS: Six studies met the inclusion criteria. One trial compared vas occlusion with clips versus a conventional vasectomy technique. No difference was found in failure to reach azoospermia. Three trials examined vasectomy with vas irrigation. Two studies looked at irrigation with water versus no irrigation, while one examined irrigation with water versus the spermicide euflavine. None found a difference between the groups for time to azoospermia. However, one trial reported that the median number of ejaculations to azoospermia was lower in the euflavine group compared to the water irrigation group. One high-quality trial compared vasectomy with fascial interposition versus vasectomy without fascial interposition. The fascial interposition group was less likely to have vasectomy failure. Fascial interposition had more surgical difficulties, but the groups were similar in side effects. Lastly, one trial found that an intra-vas was less likely to produce azoospermia than was no-scalpel vasectomy. More men were satisfied with the intra-vas device, however. AUTHORS' CONCLUSIONS: For vas occlusion with clips or vasectomy with vas irrigation, no conclusions can be made as those studies were of low quality and underpowered. Fascial interposition reduced vasectomy failure. An intra-vas device was less effective in reducing sperm count than was no-scalpel vasectomy. Randomized controlled trials examining other vasectomy techniques were not available. More and better quality research is needed to examine vasectomy techniques.

Scalpel versus no-scalpel incision for vasectomy.

BACKGROUND: Currently, the two most common surgical techniques for approaching the vas during vasectomy are the incisional method and the no-scalpel technique. Whereas the conventional incisional technique involves the use of a scalpel to make one or two incisions, the no-scalpel technique uses a sharp-pointed, forceps-like instrument to puncture the skin. The no-scalpel technique aims to reduce adverse events, especially bleeding, bruising, hematoma, infection and pain and to shorten the operating time. OBJECTIVES: The objective of this review was to compare the effectiveness, safety, and acceptability of the incisional versus no-scalpel approach to the vas. SEARCH STRATEGY: We searched the computerized databases of CENTRAL, MEDLINE, EMBASE, POPLINE and LILACS in May 2006. In addition, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: Randomized controlled trials and controlled clinical trials were included in this review. No language restrictions were placed on the reporting of the trials. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches and two authors independently extracted data from the articles identified for inclusion. Outcome measures included safety, acceptability, operating time, contraceptive efficacy, and discontinuation. MAIN RESULTS: Two randomized controlled trials evaluated the no-scalpel technique and differed in their findings. The larger trial demonstrated less perioperative bleeding (Odds ratio (OR) 0.49; 95% Confidence Interval (CI) 0.27 to 0.89) and pain during surgery (OR 0.75; 95% CI 0.61 to 0.93), scrotal pain (OR 0.63; 95% 0.50 to 0.80), and incisional infection (OR 0.21; 95% CI 0.06 to 0.78) during follow up than the standard incisional group. Both studies found less hematoma with the no-scalpel technique (OR 0.23; 95% CI 0.15 to 0.36). Operations using the no-scalpel approach were faster and had a quicker resumption of sexual activity. The smaller study did not find these differences; however, the study could have failed to detect differences due to a small sample size as well as a high loss to follow up. Neither trial found differences in vasectomy effectiveness between the two approaches to the vas. AUTHORS' CONCLUSIONS: The no-scalpel approach to the vas resulted in less bleeding, hematoma, infection, and pain as well as a shorter operation time than the traditional incision technique. No difference in effectiveness was found between the two approaches.

Steroid hormones for contraception in men.

BACKGROUND: Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so 'add-back' therapy is needed. OBJECTIVES: To summarize all randomized controlled trials of male hormonal contraception. SEARCH STRATEGY: We searched the computerized databases CENTRAL, MEDLINE, EMBASE, POPLINE, and LILACS (each from inception to March 2006) for randomized controlled trials of hormonal contraception in men. We wrote to authors of identified trials to seek unpublished or published trials that we might have missed. SELECTION CRITERIA: We included all randomized controlled trials in any language that compared a steroid hormone with another contraceptive. We excluded non-steroidal male contraceptives, such as gossypol. We included both placebo and active-regimen control groups. All trials identified included only healthy men with normal semen analyses. DATA COLLECTION AND ANALYSIS: Azoospermia (absence of spermatozoa on semen examination) was the primary outcome measure. Data were insufficient to examine pregnancy rates and side effects. MAIN RESULTS: We found 30 trials that met our inclusion criteria. The proportion of men who achieved azoospermia varied widely in reports to date. A few important differences emerged from these trials: levonorgestrel implants combined with injectable testosterone enanthate (TE) were more effective than levonorgestrel 125 microg daily combined with testosterone patches; levonorgestrel 500 mug daily improved the effectiveness of TE 100 mg injected weekly; desogestrel 150 mug was less effective than desogestrel 300 mug (with testosterone pellets); testosterone undecanoate (TU) 500 mg was less likely to produce azoospermia than TU 1000 mg (with levonorgestrel implants); norethisterone enanthate 200 mg with TU 1000 mg led to more azoospermia when given every 8 weeks versus 12 weeks; four implants of 7-alpha-methyl-19-nortestosterone (MENT) were more effective than two MENT implants. Several trials showed promising efficacy in terms of percentages with azoospermia. Three examined desogestrel and testosterone preparations or etonogestrel (metabolite of desogestrel) and testosterone, and two examined levonorgestrel and testosterone. AUTHORS' CONCLUSIONS: No male hormonal contraceptive is ready for clinical use. Most trials were small exploratory studies. As a result, their power to detect important differences was limited and their results imprecise. In addition, the definition of oligozoospermia has been imprecise or inconsistent. To avoid bias, future trials need more attention to the methodological requirements for randomized controlled trials. More trials with adequate power would also be helpful.

Validity of self-reported 'safe sex' among female sex workers in Mombasa, Kenya--PSA analysis.

We assessed the validity of self-reported sex and condom use by comparing self-reports with prostate-specific antigen (PSA) detection in a prospective study of 210 female sex workers in Mombasa, Kenya. Participants were interviewed on recent sexual behaviours at baseline and 12-month follow-up visits. At both visits, a trained nurse instructed participants to self-swab to collect vaginal fluid specimens, which were tested for PSA using enzyme-linked immunosorbent assay (ELISA). Eleven percent of samples (n = 329) from women reporting no unprotected sex for the prior 48 hours tested positive for PSA. The proportions of women with this type of discordant self-reported and biological data did not differ between the enrolment and 12-month visit (odds ratio [OR] 1.1; 95% confidence interval [CI] 0.99, 1.2). The study found evidence that participants failed to report recent unprotected sex. Furthermore, because PSA begins to clear immediately after exposure, our measures of misreported semen exposure likely are underestimations.

Combined oral contraceptive pills for treatment of acne.

BACKGROUND: Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. OBJECTIVES: To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. SEARCH STRATEGY: We searched the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, Biological Abstracts and LILACS for randomized controlled trials of COCs and acne. We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed. SELECTION CRITERIA: All randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women were eligible. DATA COLLECTION AND ANALYSIS: We extracted data on total and specific (i.e., open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan. MAIN RESULTS: The search yielded 23 trials: 5 placebo-controlled trials made 3 different comparisons, 17 trials made 13 comparisons between 2 different COC regimens, and 1 additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel, although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found no difference between the COCs. AUTHORS' CONCLUSIONS: The three COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question.

Scalpel versus no-scalpel incision for vasectomy.

BACKGROUND: Currently, the two most common surgical techniques for approaching the vas during vasectomy are the incisional method and the no-scalpel technique. Whereas the conventional incisional technique involves the use of a scalpel to make one or two incisions, the no-scalpel technique uses a sharp-pointed, forceps-like instrument to puncture the skin. The no-scalpel technique aims to reduce adverse events, especially bleeding, bruising, hematoma, infection and pain and to shorten the operating time. OBJECTIVES: The objective of this review was to compare the effectiveness, safety, and acceptability of the incisional versus no-scalpel vasectomy approach to the vas. SEARCH STRATEGY: We searched the computerized databases of CENTRAL, MEDLINE, EMBASE, POPLINE and LILACS in May 2006. In addition, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: Randomized controlled trials and controlled clinical trials were included in this review. No language restrictions were placed on the reporting of the trials. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches and two authors independently extracted data from the articles identified for inclusion. Outcome measures included safety, acceptability, operating time, contraceptive efficacy, and discontinuation. MAIN RESULTS: Two randomized controlled trials evaluated the no-scalpel technique and differed in their findings. The larger trial demonstrated less perioperative bleeding (Odds ratio (OR) 0.49; 95% Confidence Interval (CI) 0.27 to 0.89) and pain during surgery (OR 0.75; 95% CI 0.61 to 0.93), scrotal pain (OR 0.63; 95% 0.50 to 0.80), and incisional infection (OR 0.21; 95% CI 0.06 to 0.78) during follow up than the standard incisional group. Both studies found less hematoma with the no-scalpel technique (OR 0.23; 95% CI 0.15 to 0.36). Operations using the no-scalpel approach were faster and had a quicker resumption of sexual activity. The smaller study did not find these differences; however, the study could have failed to detect differences due to a small sample size as well as a high loss to follow up. Neither trial found differences in vasectomy effectiveness between the two approaches to the vas. AUTHORS' CONCLUSIONS: The no-scalpel approach to the vas resulted in less bleeding, hematoma, infection, and pain as well as a shorter operation time than the traditional incision technique. Although no difference in effectiveness was found between the two approaches, the sample sizes might have been too small to detect actual differences. Additional well-conducted randomized trials would help answer this question.

Continuous versus cyclic use of combined oral contraceptives for contraception: systematic Cochrane review of randomized controlled trials.

BACKGROUND: With the recent US Food and Drug Administration approval of a combination oral contraceptive that causes a withdrawal bleed every 3 months instead of monthly, avoidance of menstruation through extended or continuous administration (>28 days of active pills) of combined oral contraceptives may become more commonplace for reasons of personal preference rather than limited to treatment of menstrual-associated medical disorders. METHODS: The review aimed to compare contraceptive efficacy, compliance, continuation, satisfaction, bleeding profiles, and menstrual symptoms of combined oral contraceptives with continuous dosing (>28 days of active pills) versus traditional cyclic dosing (21 days of active pills and 7 days of placebo). We searched five computerized databases as well as reference lists of relevant articles for randomized controlled trials (RCT) using continuous or extended combined oral contraceptives for contraception. Two reviewers independently extracted data from eligible articles. RESULTS: Six RCT met inclusion criteria and were of good quality. Contraceptive efficacy and compliance were similar between groups. Discontinuation overall, and for bleeding problems, was not uniformly higher in either group. When studied, participants reported high satisfaction with both dosing regimens. Five out of the six studies found that bleeding patterns were either equivalent or improved with continuous-dosing regimens. The continuous-dosing group had greater improvement of menstrual-associated symptoms (headaches, genital irritation, tiredness, bloating, and menstrual pain). CONCLUSIONS: The variations in pill type and time-interval for continuous dosing make direct comparisons between regimens unfeasible. To allow for comparisons, future studies should choose a previously researched pill and dosing regimen. More attention needs to be directed towards participant satisfaction and menstruation-associated symptoms.

Non-latex versus latex male condoms for contraception.

BACKGROUND: The male condom, which consists of a thin sheath placed over the glans and shaft of the penis, is designed to prevent pregnancy by providing a physical barrier against the deposition of semen into the vagina during intercourse. Beginning in the 1990s, nonlatex male condoms made of polyurethane film or synthetic elastomers were developed as alternative male barrier methods for individuals with allergies, sensitivities or preferences that prevented the consistent use of condoms made of latex. OBJECTIVES: The review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage and slippage, safety, and user preferences. SEARCH STRATEGY: We searched computerized databases for randomized controlled trials of nonlatex condoms. We also wrote to the manufacturers of nonlatex condoms and known investigators in an attempt to locate any other trials not identified in our search. SELECTION CRITERIA: The review included all randomized controlled trials identified in the literature search that evaluated a male nonlatex condom made of polyurethane film or synthetic elastomers in comparison with a latex condom. DATA COLLECTION AND ANALYSIS: We evaluated all titles and abstracts located in the literature searches for inclusion. Two authors independently extracted data from the identified studies. We analyzed data with RevMan. The Peto odds ratio (Peto OR) with 95% confidence interval (CI) was calculated for each outcome of contraceptive efficacy, condom breakage and slippage, discontinuation of use, safety, and user preference. Contraceptive efficacy, early discontinuation, and safety outcomes were also measured with survival analysis techniques. MAIN RESULTS: While the eZ.on condom did not protect against pregnancy as well as its latex comparison condom, no differences were found in the typical-use efficacy between the Avanti and the Standard Tactylon and their latex counterparts. The nonlatex condoms had significantly higher rates of clinical breakage than their latex comparison condoms: the Peto OR for clinical breakage ranged from 2.6 (95% CI 1.6 to 4.3) to 5.0 (95% CI 3.6 to 6.8). Few adverse events were reported. Substantial proportions of participants preferred the nonlatex condom or reported that they would recommend its use to others. AUTHORS' CONCLUSIONS: Although the nonlatex condoms were associated with higher rates of clinical breakage than their latex comparison condoms, the new condoms still provide an acceptable alternative for those with allergies, sensitivities, or preferences that might prevent the consistent use of latex condoms. The contraceptive efficacy of the nonlatex condoms requires more research.

Combination contraceptives: effects on weight.

BACKGROUND: Weight gain is often considered a side effect of combination hormonal contraceptives, and many women and clinicians believe that an association exists. Concern about weight gain can limit the use of this highly effective method of contraception by deterring the initiation of its use and causing early discontinuation among users. However, a causal relationship between combination contraceptives and weight gain has not been established. OBJECTIVES: The aim of the review was to evaluate the potential association between combination contraceptive use and changes in weight. SEARCH STRATEGY: We searched the computerized databases MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS for studies of combination contraceptives. We also wrote to known investigators and manufacturers to request information about other published or unpublished trials not discovered in our search. SELECTION CRITERIA: All English-language, randomized controlled trials were eligible if they had at least three treatment cycles and compared a combination contraceptive to a placebo or to a combination contraceptive that differed in drug, dosage, regimen, and/or study length. DATA COLLECTION AND ANALYSIS: All titles and abstracts located in the literature searches were assessed. Data were entered and analyzed with RevMan, and a second author verified the data entered. Depending on the data available, the weighted mean difference using a fixed effects model with 95% confidence intervals (CI) was calculated for the mean change in weight between baseline and post-treatment measurements or the Peto odds ratio with 95% confidence intervals was calculated using the proportion of women who gained or lost more than a specified amount of weight. MAIN RESULTS: The three placebo-controlled, randomized trials did not find evidence supporting a causal association between combination oral contraceptives or a combination skin patch and weight gain. Most comparisons of different combination contraceptives showed no substantial difference in weight. In addition, discontinuation of combination contraceptives because of weight gain did not differ between groups where this was studied. AUTHORS' CONCLUSIONS: Available evidence was insufficient to determine the effect of combination contraceptives on weight, but no large effect was evident.

Strategies to improve adherence and acceptability of hormonal methods for contraception.

BACKGROUND: Worldwide, hormonal contraceptives are among the most popular reversible contraceptives in current use. Despite their high theoretical effectiveness, typical use results in much lower effectiveness. In large part, this disparity reflects difficulties in adherence to the contraceptive regimen and low rates for long-term continuation. OBJECTIVES: To determine the effectiveness of ancillary techniques to improve adherence to, and continuation rates of, hormonal methods of contraception. SEARCH STRATEGY: We searched computerized databases for randomized controlled trials (RCTs) comparing client-provider interventions with standard family planning counseling. Sources included CENTRAL, MEDLINE, EMBASE, POPLINE, LILACS, and PsycINFO. SELECTION CRITERIA: Randomized controlled trials (RCTs) of an intensive counseling technique or client-provider intervention versus routine family planning counseling. Interventions included group motivation; structured, peer, or multi-component counseling; and intensive reminders of appointments. Outcome measures were discontinuation, reasons for discontinuation, number of missed pills and on-time injections, and pregnancy. DATA COLLECTION AND ANALYSIS: The primary author evaluated all titles and abstracts from the searches to determine eligibility. Two authors independently extracted data from the included studies. With RevMan 4.2, we calculated the odds ratio for all dichotomous outcomes and the weighted mean difference for continuous data. The studies were so different that we could not conduct a meta-analysis. MAIN RESULTS: We found six RCTs; only one showed a statistically significant benefit of the experimental intervention. In that trial, women who received repeated, structured information about the injectable contraceptive depo-medroxyprogesterone acetate (DMPA) were less likely to have discontinued the method by 12 months (OR 0.27; 95% CI 0.16 to 0.44) than were women who had routine counseling. The intervention group was also less likely to discontinue due to menstrual disturbances. In another study, the intervention group was less likely to discontinue due to dissatisfaction with the contraceptive method, but overall continuation was not affected. AUTHORS' CONCLUSIONS: Most studies to date have shown no benefit of strategies to improve adherence and continuation. These trials have important limitations, however. Two had small sample sizes, several had high losses to follow-up, and the intervention and its intensity varied across the studies. High-quality research is a priority, since adherence and continuation are fundamentally important to the successful use of hormonal contraceptives.

Combination injectable contraceptives for contraception.

BACKGROUND: Combination injectable contraceptives provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of combination injectable contraceptives. SEARCH STRATEGY: We searched computerized databases for randomized controlled trials of combination injectable contraceptives. SELECTION CRITERIA: Randomized controlled trials reported in any language were eligible if they compared a combination injectable with any other contraceptive method (e.g., a second combination injectable contraceptive, progestin-only injectable contraceptive, other hormonal contraceptive or barrier method) or placebo. We limited the review to currently marketed combination injectable contraceptives. DATA COLLECTION AND ANALYSIS: The primary reviewer evaluated all titles and abstracts from the literature searches to determine their eligibility. Two reviewers independently extracted data from the eligible trials. Data on contraceptive efficacy, bleeding patterns, continuation, and side effects were entered and analyzed with RevMan 4.2. MAIN RESULTS: Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5 mg. These combination injectable contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems, but had higher rates of discontinuation due to other reasons than the progestin-only comparison contraceptives. Studies comparing two combination injectable contraceptives found that NET-EN 50 mg plus E(2)V 5 mg resulted in less overall early discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials making this comparison. The NET-EN plus E(2)V group also had more cyclical (regular) bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation rates are dependent on many other factors. Future research should be directed toward interventions to improve the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinical sites, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.

Continuous or extended cycle vs. cyclic use of combined oral contraceptives for contraception.

BACKGROUND: The avoidance of menstruation through extended or continuous administration (greater than 28 days of active pills) of combination oral contraceptives (COCs) has gained legitimacy through its use in treating endometriosis, dysmenorrhea, and menstruation-associated symptoms. Avoidance of menstruation through continuous use of COCs for reasons of personal preference may have additional advantages to women, including improved compliance, greater satisfaction, fewer menstrual symptoms, and less menstruation-related absenteeism from work or school. OBJECTIVES: To determine the differences between COCs dosed continuously (greater than 28 days of active pills) compared with traditional cyclic dosing (21 days of active pills and 7 days of placebo). Our hypothesis was that continuously administered COCs have equivalent efficacy and safety but improved bleeding profiles, amenorrhea rates, adherence, continuation, participant satisfaction, and menstrual symptoms compared with cyclic COCs. SEARCH STRATEGY: We searched computerized databases (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, POPLINE, LILACS) for trials using continuous or extended COCs during the years 1966 to 2005. We also searched the references in review articles and publications identified for inclusion in the protocol. Investigators were contacted regarding additional references. SELECTION CRITERIA: All randomized controlled trials in any language comparing continuous (greater than 28 days of active pills) versus traditional cyclic administration (21 days of active pills and 7 days of placebo) of COCs for contraception. DATA COLLECTION AND ANALYSIS: Titles and abstracts identified from the literature searches were assessed for potential inclusion. Data were extracted onto data collection forms and then entered into RevMan 4.2. Peto odds ratios with 95% confidence intervals were calculated for all outcomes for dichotomous outcomes. Weighted mean difference was calculated for continuous outcomes. The trials were critically appraised by examining the following factors: study design, blinding, randomization method, group allocation concealment, exclusions after randomization, loss to follow-up, and early discontinuation. Because the included trials did not have a standard treatment (type of pill and time length for continuous dosing), we could not aggregate data into meta-analysis. MAIN RESULTS: Six randomized controlled trials met our inclusion criteria. Study findings were similar between 28-day and extended cycles in regard to contraceptive efficacy (i.e., pregnancy rates) and safety profiles. When compliance was reported, no difference between 28-day and extended cycles was found. Participants reported high satisfaction with both dosing regimens, but this was not an outcome universally studied. Overall discontinuation and discontinuation for bleeding problems were not uniformly higher in either group in most studies. The few studies that reported menstrual symptoms found that the extended cycle group fared better in terms of headaches, genital irritation, tiredness, bloating, and menstrual pain. Five out of the six studies found that bleeding patterns were either equivalent between groups or improved with continuous-dosing regimens. Endometrial lining assessments by ultrasound were done in a small number of participants but all endometrial stripe measurements were less than 5 mm. AUTHORS' CONCLUSIONS: Evidence from existing randomized control trials comparing COCs given continuously (greater than 28 days of active pills) to traditional monthly cyclic dosing (21 days of active pills and 7 days of placebo) is of good quality. However, the variations in type of pill and time length for continuous dosing make direct comparisons between regimens impossible. Future studies should choose a previously described type of pill and dosing regimen. More attention needs to be directed towards participant satisfaction and menstruation-associated symptoms.

20 mcg versus >20 mcg estrogen combined oral contraceptives for contraception.

BACKGROUND: Concern about estrogen-related adverse effects has led to progressive reductions in the estrogen dose in combination oral contraceptives (COCs). However, reducing the amount of estrogen to improve safety also could result in decreased contraceptive effectiveness and unacceptable changes in bleeding patterns. OBJECTIVES: To test the hypothesis that COCs containing 20 mcg in terms of contraceptive effectiveness, bleeding patterns, discontinuation, and side effects. SEARCH STRATEGY: We searched computerized databases (CENTRAL, MEDLINE, EMBASE, and POPLINE) from their inception to November 2003, searched the references of eligible trials, and wrote to oral contraceptive manufacturers to identify eligible trials. SELECTION CRITERIA: English-language reports of randomized controlled trials that compare a COC containing 20 mcg EE were eligible. We excluded studies where the interventions were designed to be administered for less than three consecutive cycles or to be used primarily as treatment for non-contraceptive conditions. Trials had to report on contraceptive effectiveness, bleeding patterns, trial discontinuation due to bleeding-related reasons or other side effects, or side effects to be included in the review. DATA COLLECTION AND ANALYSIS: The primary reviewer evaluated all titles and abstracts located in the literature searches to determine whether they met the inclusion criteria. Two reviewers independently extracted data from the studies identified for inclusion. We wrote to the authors when clarifications or additional data were needed. Data were entered and analyzed with RevMan 4.2. MAIN RESULTS: No differences were found in contraceptive effectiveness for the 11 COC pairs for which this outcome was reported. Several COCs containing 20 mcg EE resulted in higher rates of early trial discontinuation (overall and due to adverse events such as irregular bleeding) as well as increased risk of bleeding disturbances (both amenorrhea/infrequent bleeding and irregular, prolonged, frequent bleeding, or breakthrough bleeding or spotting) than their higher-estrogen comparison pills. AUTHORS' CONCLUSIONS: While COCs containing 20 mcg EE may be theoretically safer, this review did not focus on the rare events required to assess this hypothesis. Data from randomized controlled trials are inadequate to detect possible differences in contraceptive effectiveness. Low-dose estrogen COCs resulted in higher rates of bleeding pattern disruptions. However, most trials compared COCs containing different progestin types, and changes in bleeding patterns could be related to progestin type as well as estrogen dose.

Fertility awareness-based methods for contraception.

BACKGROUND: "Fertility awareness-based methods" (FAB) of family planning "involve identification of the fertile days of the menstrual cycle, whether by observing fertility signs such as cervical secretions and basal body temperature, or by monitoring cycle days. FAB methods can be used in combination with abstinence or barrier methods during the fertile time" (WHO 2000). Several names have been used to describe this approach to contraception, including "rhythm," "natural family planning" and "periodic abstinence." Fertility awareness-based methods can be used with abstinence from sexual intercourse. Alternatively, they can be used with barrier contraceptives or withdrawal during presumed fertile times. OBJECTIVES: We retrieved and analyzed all randomized controlled trials that examined any fertility awareness-based methods used for contraception. SEARCH STRATEGY: We searched the computerized databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, POPLINE, EMBASE, and LILACS (each from its inception to January, 2004) for randomized controlled trials of fertility awareness-based methods. We examined the reference list of each trial as well as that of review articles. SELECTION CRITERIA: We included all randomized controlled trials in any language that compared any fertility awareness-based methods for contraception with a placebo; another method, including an alternative fertility awareness-based method; or fertility awareness-based methods used in conjunction with another contraceptive. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts found for inclusion. We evaluated the methodological quality of the trials for potential biases by qualitatively assessing the study design; randomization method; allocation concealment; blinding; premature discontinuation rates; and loss to follow-up rates. Because of methodological weaknesses, we could not enter the trial results in RevMan, calculate measures of association, or aggregate data. MAIN RESULTS: Because of poor methods and reporting, pregnancy rates could not be determined. A trial in Colombia found similar numbers of pregnancies among women randomized to the ovulation and symptothermal methods. In contrast, a companion trial in Los Angeles observed more pregnancies in the group assigned to the ovulation method. In the two U.S. trials, recruitment of participants was unexpectedly difficult; this aspect was not mentioned in the report from Colombia. Continuation rates were poor. In the two larger trials, most participants discontinued their assigned method before entering the observation phase of the trial. REVIEWERS' CONCLUSIONS: The comparative efficacy of fertility awareness-based methods of contraception remains unknown. Despite intensive training and ongoing support, most participants in these trials discontinued prematurely. Contraceptive methods should be properly evaluated, preferably in randomized controlled trials, before adoption and dissemination.

Vasectomy techniques for male sterilization: systematic Cochrane review of randomized controlled trials and controlled clinical trials.

BACKGROUND: The review aimed to compare the effectiveness, safety and acceptability of vasectomy techniques for male sterilization. METHODS: We searched five computerized databases and reference lists of relevant articles and book chapters for randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing vasectomy techniques. Two reviewers independently extracted data from eligible articles. RESULTS: Two poor-quality trials compared vas occlusion with clips versus a conventional technique, and four poor-quality trials examined vas irrigation with water versus no irrigation or irrigation with euflavine. No significant differences regarding the primary outcome of time to azoospermia were found. However, one trial reported fewer median number of ejaculations to azoospermia with euflavine rather than water irrigation. An interim report of a high-quality trial comparing vasectomy with and without fascial interposition found more azoospermia with fascial interposition but also more surgical difficulties. CONCLUSIONS: No conclusions can be reached regarding the effectiveness, safety and acceptability of vas occlusion techniques or vas irrigation since only low-quality, underpowered studies were available. Fascial interposition had improved vasectomy success but also increased surgical difficulty. High-quality, adequately reported RCTs are required. More work is also needed in the standardization of follow-up protocols, evaluation of vasectomy success and failure, recanalization and analytical methods.

Vasectomy occlusion techniques for male sterilization.

BACKGROUND: Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide including various vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), vas irrigation and fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the best available evidence from randomized controlled trials. OBJECTIVES: The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization. SEARCH STRATEGY: We searched the computerized databases the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Popline and LILACS. In addition, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: We included randomized controlled trials and controlled clinical trials comparing vasectomy techniques. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches and two reviewers independently extracted articles identified for inclusion. Data were presented in the text of the review. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. MAIN RESULTS: Two trials compared vas occlusion with clips versus a conventional vasectomy technique; both were of poor quality. Neither trial found a difference between the two groups with regard to the primary outcome of failure to reach azoospermia. Four trials examined vas irrigation: three compared water irrigation with no irrigation and one compared water irrigation with euflavine. All of the trials were of poor quality. None of the trials found a significant difference between the groups with respect to the primary outcome of time to azoospermia. However, one trial found that the median number of ejaculations to azoospermia was significantly lower in the euflavine group compared to the water irrigation group. The one trial that compared vasectomy with fascial interposition versus vasectomy without fascial interposition was a high quality, large study that has only been partially reported at the time of this review. The fascial interposition group was significantly more likely to be related to vasectomy success (azoospermia) at 22 weeks. However, fascial interposition also was associated with significantly more surgical difficulties. REVIEWERS' CONCLUSIONS: No conclusions can be made about the effectiveness, safety, acceptability and costs of vas occlusion technique or vas irrigation as studies that examined these were of low quality and underpowered. Fascial interposition is associated with improved vasectomy success but is associated with some increased surgical difficulty. Randomized controlled trials examining other vasectomy techniques were not available. More research is required to examine vasectomy techniques.

Combined oral contraceptive pills for treatment of acne.

BACKGROUND: Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. OBJECTIVES: To determine the effectiveness of COCs for the treatment of facial acne compared to placebo or other active therapies. SEARCH STRATEGY: We searched the computerized databases Cochrane Skin Group trial register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, Biological Abstracts and LILACS for randomized controlled trials of COCs and acne. We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed. SELECTION CRITERIA: All randomized controlled trials reported in any language that compare the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women were eligible. DATA COLLECTION AND ANALYSIS: We extracted data on total and specific (i.e. open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan 4.2. MAIN RESULTS: The search yielded five placebo-controlled trials that made three different comparisons and 14 trials that made nine comparisons between two COC regimens. An additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogrestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found no difference between the COCs. REVIEWERS' CONCLUSIONS: The three COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few differences were found in acne effectiveness between COC types. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question.

Nonlatex vs. latex male condoms for contraception: a systematic review of randomized controlled trials.

This systematic review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage, slippage, safety and user preferences. We searched computerized databases and contacted manufactures and investigators to find randomized controlled trials of nonlatex vs. latex male condoms. Two reviewers independently abstracted data from the 10 identified trials. While the eZ. on condom did not protect against pregnancy as well as its latex comparison condom, no differences were found in typical-use efficacy between the Avanti and the Standard Tactylon and their latex counterparts. Nonlatex condoms were associated with higher rates of clinical breakage than their latex comparisons, with statistically significant odds ratios of clinical breakage ranging from 2.6 (95% confidence interval [CI]: 1.6-4.3) to 5.0 (95% CI: 3.6-6.8). Few adverse events were reported. Substantial proportions of participants reported preferences for the nonlatex condoms. Despite higher rates of clinical breakage, nonlatex condoms still provide an acceptable alternative for those with allergies, sensitivities or preferences that might prevent the consistent use of latex condoms. The contraceptive efficacy of nonlatex condoms requires more research.