Safety evaluation of 1% tenofovir gel in healthy men.

This study was conducted to determine the safety of tenofovir (TFV) gel, a potential microbicide, following seven consecutive daily penile applications. Eighteen circumcised and 18 uncircumcised healthy men were randomly assigned to TFV gel versus K-Y Jelly in a 2:1 ratio within circumcision group. TFV gel or K-Y Jelly was applied onto the penis at bedtime and washed off 6-10 hours later. Safety was assessed by reported symptoms, findings and laboratory tests. Three of 24 (13%) men in the TFV group reported mild genital symptoms compared with two of 11 (18%) men in the K-Y group. Few mild genital findings were observed and no significant systemic toxicities were reported or observed. TFV gel applied to the penis for seven days was well tolerated locally and systemically and it is unlikely that male partners exposed to small amounts of TFV gel will experience significant genital or systemic toxicity.

Extra-relational sex among Hispanic women and their condom-related behaviours and attitudes.

Limited data are available concerning sexual behaviour of Hispanic women. A total of 318 Hispanic women were surveyed concerning extra-relational sex and their condom-related attitudes. Fifteen per cent of the sample had a secondary sex partner (apart from the first partner) during the three months preceding the survey. Of these women, 77 and 53% used condoms with their secondary and primary partners, respectively. Among women in monogamous relationships, condom use was low (17%), and nearly two-thirds (61%) of those with a high-risk partner did not use condoms. The most common concerns about condom use among these Hispanic women were a reduction in pleasurable sensations and embarrassment associated with buying condoms. Women with concurrent partners as compared to those with a single partner felt more at risk for HIV and STDs, were less likely to believe condoms have side effects or are unacceptable to their male partners and were more able to use condoms in long-term relations. In conclusion, extra-relational sex among Hispanic women may be higher than previously reported, although more favourable attitudes to condom use are seen among women with concurrent than those with a single partner. HIV/STD programmes in the Hispanic community should tailor to the sexual behaviour of their participants.

Previous cesarean section. A contraindication to vaginal hysterectomy?

OBJECTIVE: To compare surgical outcomes of vaginal hysterectomy between women who have had one or more cesarean deliveries and those who have not. STUDY DESIGN: A retrospective, chart review study was performed on women undergoing vaginal hysterectomy during a four-year period. Of 275 women who met the study criteria, 104 had a history of previous cesarean deliveries, and 171 did not. The groups were compared for indications for surgery, operative time, length of hospitalization and surgical complications. RESULTS: Previous cesarean delivery did not affect hemoglobin loss, hospital stay or operative time among women undergoing vaginal hysterectomy. The complication rate (either operative or postoperative) was 12.3% among women without a history of cesarean section, 6.8% among those with one, 3.7% among those with two and 11.1% among those with three or more (chi 2 = 2.8, P = .4). The odds for surgical complications were not significantly different between women with one or more prior cesarean deliveries as compared to those without after adjustment for possible confounders. CONCLUSION: Surgical complications with vaginal hysterectomy do not appear to be higher among women with a prior cesarean section as compared to those without a history of such operation.

Condom use among sterilized and nonsterilized Hispanic women.

BACKGROUND: Women who use sterilization for contraception are at risk for various sexually transmitted diseases, unless they use a barrier method. Use of condoms is significantly lower among sterilized women than among hormonal-contraceptive users. Among Hispanics, women's perception of risk and the influence of male partners are strong correlates of dual-method use. Limited data are available concerning use of condoms among sterilized women, in particular among Hispanics. GOALS: Past and future use of condoms was examined and compared among 224 sterilized women and 104 hormonal-contraceptive users of Hispanic origin, and the reasons for use or nonuse of condoms were examined. STUDY DESIGN: Cross-sectional survey. RESULTS: As compared with hormonal-contraceptive users, sterilized women were significantly less likely to have used condoms in the 3 months before the study or to have plans to use them in the future (P < 0.001). Despite similarities between various HIV-related characteristics of sterilized and nonsterilized women, the former group had significantly lower perceptions of being at risk for both HIV and other sexually transmitted diseases. Sterilized women were also more likely to have used condoms for the purposes of dual protection from pregnancy. The strongest correlates of consistent condom use by both sterilized and nonsterilized Hispanic women were their perceived susceptibility to disease, male partners' positive opinion about condoms, and the women's ability to use condoms in long-term relationships. Furthermore, the practice of concealing the use of a contraceptive from a male partner was not uncommon, although this characteristic was not related to increased dual-method use. CONCLUSIONS: Sterilized women may be at a higher risk of disease than hormonal-contraceptive users. Among Hispanics, women's perception of risk and male partners' influences predict whether the women protect themselves from pregnancy and disease simultaneously.

The emerging use of the 20-microg oral contraceptive.

OBJECTIVE: To highlight studies that investigated the efficacy, safety, and tolerability of low-dose oral contraceptives (OCs) containing 20 microg of ethinyl estradiol (EE) and to discuss the use of these low-dose contraceptives in women from adolescence to menopause and the noncontraceptive health benefits likely to be afforded by low-dose contraceptives. DESIGN: Relevant literature was identified by searching MEDLINE and EMBASE. Other sources were located by consulting the bibliographies of the material collected from Medline and EMBASE. Sources for additional information included documents from the United States Food and Drug Administration and the Physicians' Desk Reference (54th ed.). CONCLUSION(S): The current lowest available dose of EE used for OCs in the United States is 20 microg. Formulations with 20 microg of EE are efficacious and have a low incidence of estrogen-related side effects. Since this lowest effective EE dose inhibits ovarian activity, 20 microg of EE should also provide the noncontraceptive health benefits of OCs. Both contraceptive and noncontraceptive benefits of OCs are available to most women from adolescence to menopause without complications.

A qualitative study of perceptions, attitudes, and experiences of long-term levonorgestrel implant users.

The present study examined the perceptions, attitudes, and experiences of long-term contraceptive implant users. Group interviews were conducted to obtain qualitative in-depth attitude and opinion data from 31 women who had used the implant for a minimum of four years. Results indicated that many women had experienced side effects with implant use, in particular during the first year. The primary motivations for continuing the use of implant were: women's strong desire for a long-term, reversible, and convenient method that offered effective protection from pregnancy, a strong need for control over one's life, and general dissatisfaction with alternative methods. Exposure to negative media reports, and peer commentaries did not influence implant's continued use. However, intensive educational counseling prior to insertion played a significant role in the long-term use of implant. Findings from this study indicate that women are willing to accept side effects as the price to be paid for an effective and convenient contraceptive method, and for gaining control over their lives. Furthermore, women appear to be less influenced by opposing social climate, in the absence of negative personal experiences. Our findings underscore the importance of educational counseling prior to implant insertion.

Aggression and psychopathology in persons with severe or profound mental retardation.

We examined aggression and psychopathology in persons with severe or profound mental retardation. Most aggressive episodes were directed toward other clients, and ratings of aggression were positively correlated with self-injury, stereotypic behavior, and being ambulatory. In a linear regression analysis of psychopathological correlates, aggression was most consistently predicted by dependent personality and psychosis. To better describe the construct of aggression, we also developed an Aggression-psychopathology scale. Persons with mental retardation and aggression were more likely to be impulsive, attention-seeking, dependent, socially inadequate, and anxious. Intensive efforts to modify the psychopathological correlates of aggression may improve treatment planning and outcome.

Planned condom use among women undergoing tubal sterilization.

BACKGROUND AND OBJECTIVES: Women who are undergoing tubal sterilization are at risk for various sexually transmitted diseases (STDs) if they do not use a barrier method of contraception. There is a paucity of data concerning dual use of condoms among sterilized women. GOAL: Planned use of condoms for protection against STDs was examined among 2,782 women undergoing surgical sterilization from 1991 to 1996. STUDY DESIGN: Cross-sectional survey. RESULTS: Planned condom use increased significantly over the 6-year study period. Of women who were using condoms before sterilization (n = 646), nearly half indicated no plans to do so after becoming sterilized. Thus, 11% of the total sample experienced an increased risk for exposure to human immunodeficiency virus or other STDs. Condom abandonment was significantly higher among Hispanic and married women. Multiple regression analysis was used to examine the association between condom use and various characteristics. Factors associated with future condom use were younger age, black ethnicity, being unmarried, previous STD, not having a steady partner, higher number of previous sexual partners, having used condoms for disease prevention in the past, and lack of partner involvement in the decision to undergo sterilization. CONCLUSIONS: Use of condoms among sterilized women appears to be on the rise, women at higher risk for disease are more likely than others to be using condoms, and only a small group of women experience an increased risk for exposure to disease as a result of selecting this permanent method of contraception.

PIP: Women undergoing tubal sterilization are at risk of various sexually transmitted diseases (STDs) if they do not use a barrier method of contraception. The authors investigated the planned use of condoms for protection against STDs among 2782 women undergoing surgical sterilization during 1991-96 at the Baylor College of Medicine in Houston, Texas. The women were 18-50 years old (mean age, 30.3 years); 62% were Hispanic, 20% Black, and 17% White. 31% reported being unmarried, the mean level of educational attainment was 9.8 years, and 20% had a known risk factor for HIV. 646 of the women reported regular condom use during the 3 months before being sterilized, of whom 45% had no plans to continue their practice after becoming sterilized. 11% of the total sample therefore planned to stop using condoms once sterilized. Among Hispanic, White, and Black women, respectively, 55%, 36%, and 18% planned to stop condom use once sterilized. Also, among former condom users, 54% of married women and 21% of unmarried women planned to abandon condom use. Factors found through multiple regression analysis to be associated with future condom use were younger age, being Black, unmarried status, having previously had a STD, not having a steady sex partner, having a relatively higher number of previous sex partners, having ever used condoms to prevent disease, and lack of partner involvement in the decision to be sterilized. The planned future use of condoms among women undergoing sterilization increased steadily and significantly from 1991 to 1996, irrespective of age, marital status, or ethnic background.

Factors associated with unintended pregnancy.

This research was designed to identify determinants of unintended pregnancy among women attending family practice or family planning clinics. Survey data were collected from 95 women who were categorized according to whether or not they had experienced an unintended pregnancy. Women reporting unintended pregnancy were younger, reported earlier sexual debut and a greater number of sexual partners than those not having experienced an unintended pregnancy. Those who had avoided unintended pregnancy displayed higher levels of preventive sexual self-efficacy, had more confidence in their ability to use contraceptive methods, perceived more negative consequences associated with having children in the near future, and believed pregnancy among unmarried women to be less acceptable than did women who had had unintended pregnancies.

Third-generation oral contraceptives and thromboembolism risk.

Recently, observational studies have suggested an increased risk of nonfatal venous thromboembolic complications in women using oral contraceptives (OCs) containing the third-generation progestins, gestodene and desogestrel. Because of the observational, rather than randomized, nature of these trials, the clinical relevance of these findings is difficult to interpret. Each study included one or more potential sources of bias. In particular, cases came almost exclusively from hospitalized patients with nonfatal venous thromboembolism, which represents only a minority of patients diagnosed with this condition according to current clinical practice. In the absence of a sound biologic rationale to explain the increased risk with third-generation OCs, and considering the potential sources of bias within the current studies, an alternative view argues against causality. Oral contraceptives remain safe and effective. Clearly, additional research is needed to determine the relationship between thromboembolic disease and the use of third-generation OCs. In the interim, women should be informed thoroughly with objective data on all risks associated with the use of OCs.

Consistency of condom use among users of injectable contraceptives.

Use of condoms for protection against sexually transmitted diseases (STDs) was examined over a nine-month period among 536 women from 17 clinics in southeastern Texas who had selected the injectable depot-medroxyprogesterone acetate (DMPA) as a contraceptive. Among women who were using condoms prior to receiving DMPA, nearly half said they never or rarely did so after initiating DMPA use; only 18% of all women in the study used condoms consistently while relying on DMPA. Factors associated with consistent condom use were being black (odds ratio of 2.0), being unmarried (odds ratio of 2.2), having a history of STD infection (odds ratio of 1.8), having previously used condoms (odds ratio of 2.7) and having no interest in future childbearing (odds ratio of 1.8). Our data suggest that the majority of users of injectables may not be protected from exposure to the human immunodeficiency virus and other STDs.

Differential expression of uterine progesterone receptor forms A and B during the menstrual cycle.

Recent studies suggest that the progesterone receptor isoforms (PR-A and PR-B) activate genes differentially and that PR-A may act as a repressor of PR-B function. Hence, the absolute and relative expression of the two isoforms will determine the response to progesterone. We have measured their relative expression in the uterus of cycling women who underwent endometrial biopsy. PR isoforms were identified on blots of SDS-PAGE gels by reaction with the AB-52 antibody after immunoprecipitation from endometrial extract. Both isoforms were highest in the peri-ovulatory phase, but levels of PR-A were always higher than those of PR-B. The ratio of PR-A to PR-B changed during the menstrual cycle. Between days 2 and 8, PR-B is almost undetectable and the A:B ratio is >10:1. From days 9 to 13, the ratio is about 5:1, and it is about 2:1 between days 14 and 16. Thereafter, PR-B dwindles rapidly and is virtually undetectable at the end of the cycle. In various hypoestrogenic environments, PR-B expression was reduced. However, exogenous estrogens in the follicular phase in the form of oral contraceptives, enhanced PR-B expression. These data support the possibility that progesterone acts through cycle-specific PR isoforms.

Insulin-like growth factor binding proteins in peritoneal fluid of women with minimal and mild endometriosis.

This prospective cohort study was carried out in a university-based infertility clinic to determine the profile of insulin-like growth factor binding proteins (IGFBPs) in patients with mild endometriosis and no obvious mechanical factor contributing to infertility. A total of 26 patients with minimal and mild endometriosis and 10 controls contributed peritoneal fluid at surgery. The variety, expression and levels of IGFBPs were determined by radio-immunoassay and Western ligand blots (WLBs) with quantitation by laser densitometer. A 27 kDa species was significantly lower and 31 kDa species tended to be lower in patients with endometriosis as determined by quantitative laser densitometer. The levels of IGFBP-3 detected by radioimmunoassay and by WLB were correlated in the control group and in the patients with endometriosis in the follicular phase but not in patients with endometriosis in the luteal phase. The level of 27 kDa species seen on WLBs did not appear to correspond to IGFBP-1 determined by radioimmunoassay and IGFBP-3 levels in luteal phase endometriosis patients also departed from values determined by radioimmunoassay. These discrepancies suggest a complex system to control levels of IGF in the peritoneum involving multiple binding proteins and proteases. The IGFBPs of patients with endometriosis may contribute to reproductive dysfunction and be able to serve as markers.

Experiences of injectable contraceptive users in an urban setting.

OBJECTIVE: To examine method-related experiences and acceptability of depot medroxyprogesterone acetate (DMPA) among women using this contraceptive for the first time. METHODS: Five hundred thirty-six women who received an injection of DMPA from any of seventeen clinical settings in southeast Texas, United States, were followed for 1 year. At each follow-up visit, patients were asked about their experiences with DMPA during the past 3 months and their plans to use this method in the future. RESULTS: Amenorrhea, irregular bleeding, and weight gain were the conditions reported most frequently. Reports of amenorrhea, weight gain, and acne or skin problems increased over time, but complaints of longer periods decreased (P < .001). Two pregnancies occurred during the study period. However, of these, one existed before the first injection. Depot medroxyprogesterone acetate's continuation rate at 1 year was 28.6%. Heavier and more frequent bleeding, increased cramping, amenorrhea, weight gain, headaches, depression, and nervousness were more frequent complaints of women who discontinued DMPA (P < .05), whereas lighter and less frequent bleeding were reported more often by those who continued to use this method (P <.05). Women who discontinued use of DMPA were more likely to be married and have a concern about injectable contraceptives than those who continued to use this method. CONCLUSION: Intolerable side effects and changes in menstrual pattern are the most frequently indicated reasons for discontinuing DMPA use. Our results suggest that DMPA's 1-year continuation rate may be lower than previously reported.

Sperm transport and survival post-application of a new spermicide contraceptive. Advantage 24 Study Group.

The present study was undertaken to evaluate the effectiveness of Advantage 24 to inhibit sperm transport and survival when applied at 24 hours, 12 hours, and 15-30 minutes prior to a single act of intercourse. Conceptrol, applied at 15-30 minutes before intercourse, was employed as the comparative spermicide. One-hundred-thirty-nine women, aged 22 to 45 years, were enrolled into the study and 111 completed the trial. The ability of the spermicides to immobilize sperm was assessed by postcoital testing (PCT) and by examining the proportion of sperm immobilization failure (SIF) rates. SIF was a postcoital test result with > or = 10 sperm with progressive motility (either sluggish or rapid) per x 400 power field. Conceptrol and Advantage 24 used at 15-30 minutes were similar with respect to their ability to inactivate sperm (0% and 2% SIF, respectively, p = 0.5). At longer intervals between spermicidal application and intercourse, less inhibition of sperm motility was noted (9% and 14% SIF for 12 and 24 hours, respectively). The present study indicates that Advantage 24 is an effective agent to immobilize sperm. The action of Advantage 24 may decrease if it is applied earlier than 15-30 minutes before intercourse.

Comparison of spermicides on vulvar, vaginal, and cervical mucosa.

The objective of this study was to compare the tolerability of Advantage 24 to two other spermicides containing non-oxynol-9 (N-9). These spermicides were Today Sponge (Sponge) and Conceptrol. In order to examine the incidence of complaints and the clinical observation of vaginal ulceration and irritation of the three spermicides, a randomized, open label, three period cross-over trial was conducted. Thirty-three women, ages 18-45, with a normal vaginal environment based on physical exam, Pap smear, vaginal wet prep, colposcopy, and serum N-9 were randomized into four treatment groups. Each treatment was for seven consecutive days with a 21-day washout. Data obtained were studied by one-way analysis of variance, chi-square, and Kruskal-Wallis test. No vulvar or vaginal abnormality was observed from either spermicide. Subjects had fewer and less severe cervical lesions by colposcopy during treatment with Advantage 24 than with Conceptrol or Sponge (p < 0.01). Comparison of the incidence of abnormal gynecological findings, serum N-9 levels, and the incidence of adverse events before and after treatment with the three study drugs indicate that most subjects had normal examinations pre- and post-treatment. Pap smear and colposcopy changes from normal to abnormal accounted for about 50% of all gynecological findings during the Conceptrol and Sponge treatments, but less than 20% during treatment with Advantage 24. All serum N-9 levels were below the level of detection (< 1.9 microgram/ml). Advantage 24 is better tolerated than Conceptrol or the Sponge. Furthermore, the cervical mucosa appears to be less resilient to spermicides than vulvo-vaginal mucosa.

Characteristics and experiences of American women electing for early removal of contraceptive implants.

The study describes the experiences of 430 women who had Norplant(R) contraceptive implants removed prior to the five years of method effectiveness. Each subject was surveyed when the implants were inserted and again at the time of removal. Descriptive data are presented concerning perceptions of the method before insertion and after removal, reactions to the contraceptive and experiences associated with the removal procedure. Subjects' use of Norplant implants ranged from 14 days to 40 months, with a mean of 13.3 and median of 13 months. Over 95% reported changes in menstrual bleeding patterns and 95% experienced other non-bleeding related side effects. Non-bleeding side effects were the most frequently indicated reasons for removal, followed by bleeding changes. The mean removal time was 34 minutes with a median of 25 minutes. Over 48% reported experiencing significant pain during the removal procedure, and 27% stated that the pain was greater than expected. Despite electing for early removal of implants,the majority of women surveyed indicated satisfaction with all aspects of the method save its effect on their overall health. Although method-related side effects were intolerable for most subjects, their overall perception of the method was generally satisfactory.

PIP: 430 women enrolled at the time of acceptance in a longitudinal study of Norplant acceptability elected to have their implants removed between May 13, 1991 and September 8, 1994 (within 40 months of insertion). 225 of these women were surveyed immediately after removal, and 205 were identified during the follow-up study. The study provided information sociodemographic characteristics of the women and on 1) contraceptive method used before and after Norplant; 2) concerns about Norplant which were expressed prior to insertion; 3) reasons indicated for having implants removed; 4) changes in bleeding patterns; 5) side effects unrelated to menstrual bleeding; 6) significant pain reported during each of six stages of the removal process; and 7) user satisfaction in terms of comfort, convenience, cost, health effect, insertion, removal, and medical care. Most of the women chose early removal because they were unable to tolerate the side effects, but 13% chose removal because of discomfort at the implantation site and 10% because they no longer desired contraception. Removal was related to a pregnancy in three women (not method failure), and five others were acting on their physicians' advice. 48% of the women reported significant pain during removal, which was a larger number than expected. Since the cost-effectiveness of Norplant depends upon longterm use, it will be helpful to identify women who might be better served by a shorter term contraceptive. Despite the desire for removal, more than 25% of the women stated that they would consider Norplant use again in the future. Because side effects caused most women to discontinue, it is important that patients be properly counseled on the disadvantages of a longterm method.

Aggressive angiomyxoma of the pelvis and perineum. A case report.

BACKGROUND: Aggressive angiomyxoma of the female perineum and pelvis is a slowly growing neoplasm occurring almost exclusively in women of reproductive age. The tumor is characterized by its locally infiltrative behavior. The high recurrence rate has been attributed to incomplete surgical excision. CASE: A case of a huge, recurrent, aggressive angiomyxoma of the perineum and pelvis was treated. CONCLUSION: Correct preoperative diagnosis and assessment of simultaneous perineal and pelvic involvement indicate a combined abdominoperineal surgical approach to achieve wide, tumor-free margins.

Characteristics of injectable contraceptive users in a low-income population in Texas.

Among 600 women at 17 family planning clinics in Texas who expressed interest in using the hormonal injectable depot medroxyprogesterone acetate (DMPA), 536 (89%) actually received the injectable. Thirty percent of the DMPA recipients were younger than 21 and 77% were not married. The average numbers of pregnancies and births were 1.9 and 1.2 per woman; one-third of the women had had at least one abortion. The majority of women receiving DMPA (66%) were using it to space births. Their main sources of information about the method were friends (42%) and health care providers (37%), and the most commonly reported reason for its use was dissatisfaction with previous contraceptive methods.

PIP: The purpose of this prospective study was to add to the little data that exists concerning the characteristics and attitudes of depot medroxyprogesterone acetate (DMPA) users. Among 600 women at 17 family planning clinics in Texas who expressed interest in using the hormonal injectable DMPA, 536 (89%) actually received the injectable. DMPA users were significantly more likely than other women to be 20-24 years old, whereas a smaller percentage were 30 or older (p 0.001). 30% of the DMPA recipients were younger than 21; 50% were Black; and the rest were either White (25%) or Hispanic (24%). 77% of women adopting DMPA were not married. In contrast, most of the other patients who received contraceptive care at these clinics were married (64%; p 0.001). The average education of the DMPA acceptors was 11.9 years: Hispanic women had significantly less education (10.6 years) than did either Blacks or Whites (p or= 0.001). The average numbers of pregnancies and births were 1.9 and 1.2 per woman; 1/3 of the women had had at least 1 abortion. 34% of the women indicated they had no desire for more children. The majority of women receiving DMPA (66%) were using it to space births. Their main sources of information about the method were friends (42%) and health care providers (37%). 58% of the women reported dissatisfaction with previous contraceptive methods as the reason for its use, while 42% chose it because they were curious about it. 17% of the women were concerned about the method's effect on future pregnancies and 10% about the women's ability to conceive. In addition, a possible hormonal effect and the newness of the method were each cited by about 15% of DMPA users. The most frequently cited reasons for not receiving the injection involved the fear of bleeding (21%), acne or skin problems (21%), abdominal pain (19%), and weight gain (14%). One potential limitation of these findings is that the attitudes of women of lower socioeconomic status about DMPA may differ from their more affluent counterparts.