Acceptability of the female condom among sex workers in Thailand: results from a prospective study.

BACKGROUND: The female condom may provide women with the first female-controlled barrier method that is effective against sexually transmitted diseases, including HIV infection. GOAL: This study evaluated the acceptability of the female condom among sex workers in Thailand. STUDY DESIGN: Data on use and acceptability of the female condom were collected using a structured questionnaire during an 8-week follow-up. RESULTS: Analyses included 148 women who were still in follow-up at week 8. Sex workers used, on average, 2.8 female condoms per week. The overall satisfaction rate with the female condom was 68%, although, among users, 31% had difficulties in device insertion, 37% had pain from the inner ring, and 22% reported itching sensations. The main reason for using the female condom in the future was its perceived safety, and the main reason for not using it would be the client's refusal. CONCLUSION: Two-thirds of the sex workers were satisfied with the female condom. Difficulties at insertion, discomfort during use, and clients' attitude were potential obstacles to the use of the female condom in the future.

Levonorgestrel concentrations during 7 years of continuous use of Jadelle contraceptive implants.

Serum levonorgestrel concentrations were assayed in a multicenter, 7-year study of 199 users of Jadelle rod implants. We examined drug levels, patterns of changes, factors affecting drug levels, and concentrations at which pregnancies occurred. Mean levonorgestrel concentrations declined from 435 pg/mL at 1 month of use to 64% of that value (280 pg/mL) at the end of 3 years. Between the end of the third and fifth years neither mean nor median serum levels varied markedly. At 5 years the mean concentration was again 64% of the first month's mean. Declining levels were observed thereafter through the end of 7 years when the mean, 224 pg/mL, was 52% of the 1-month value. Last measured drug concentrations of women who became pregnant during Jadelle use had mean and median values of 152 and 144 pg/mL, respectively, and a maximum value of 180 pg/mL. Analyses indicated ponderal index, body weight, duration of use, and a single clinical center were the most important variables affecting measured levonorgestrel levels. Approximately one-third of assays in the sixth and seventh years were found to be below 180 pg/mL, suggesting that Jadelle levonorgestrel implants would not maintain sufficiently high levels of effectiveness against pregnancy after 5 years and that heavier women would then be at greater risk of pregnancy.

Prolonged effectiveness of Norplant(R) capsule implants: a 7-year study.

Soft tubing Norplant(R) contraceptive implants were studied in 1210 women for 7 years to measure the duration of effectiveness and the magnitude of the pregnancy rates over that time. Mean age at enrollment was 27.4 years. Of the enrollees, 42% were US residents. One-sixth (16.1%) weighed >/=70 kg at the time of implant placement. At the end of 5 years, the cumulative pregnancy rate was 1.1/100; at the end of 7 years, it was 1.9/100. No pregnancies occurred to any of the 400 women who enrolled in the study at age >/=30 years and who weighed <100 kg. Among women aged 18-33 years, the 7-year Norplant pregnancy rates are comparable to the median pregnancy rates of tubal sterilization methods for women of the same age and duration of use. For women aged >/=34 years, without regard to weight at admission, the 7-year effectiveness of soft tubing Norplant equals or surpasses that of tubal sterilization. For continuing implant users, annual pregnancy rates <1.0/100 in years 6 and 7, together with low cumulative pregnancy rates, testify that Norplant capsule implants remain highly effective for 7 years.

Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial.

BACKGROUND: The male condom is the most effective barrier method available for protection against sexually transmitted diseases (STDs), including HIV infection. There is an urgent need to develop and evaluate other prevention methods, such as the female condom. This study estimated the additional protection against STDs offered to sex workers by giving them the option of using the female condom when clients refused to use a male condom. METHODS: Sex establishments in four cities in Thailand were randomized into two study groups: one in which sex workers were instructed to use male condoms consistently (male condom group); and one in which sex workers had the option of using the female condom if clients refused or were not able to use male condoms (male/female condom group). Randomization was done by sex establishments, and not by individuals, to minimize sharing of female condoms across study groups. The proportion of unprotected sexual acts (defined as sexual acts in which condoms were not used, tore, or slipped in or out) and incidence rate of STDs (gonorrhoea, chlamydial infection, trichomoniasis and genital ulcer disease) were measured over a 24-week period and compared between the two study groups. FINDINGS: Results are available from 34 sex establishments (249 women) in the male/female condom group, and 37 sex establishments (255 women) in the male condom group. Condom use was very high in both groups (97.9 and 97.3 % of all sexual acts, respectively, P > 0.05). Male condom use was lower in the male/female condom group when compared with the male condom group (88.2 and 97.5%, respectively, P < 0.001). However, this reduction in male condom use was counterbalanced by the use of female condoms in 12.0% of all sexual acts in the male/female condom group, contributing to a 17% reduction in the proportion of unprotected sexual acts in this group when compared to the male condom group (5.9 versus 7.1%, respectively, P = 0.16). Female condom use was sustained over the entire study period. There was also a 24% reduction in the weighted geometric mean incidence rate of STDs in the sex establishments of the male/female condom group compared to the male condom group (2.81 versus 3.69 per 100 person-weeks, P = 0.18).

A 4-year pilot study on the efficacy and safety of Implanon, a single-rod hormonal contraceptive implant, in healthy women in Thailand.

OBJECTIVE: To investigate the contraceptive efficacy, safety and acceptability of a new single-rod, progestogen-only contraceptive implant (Implanon). METHODS: In an open, non-comparative pilot study, 100 healthy women received a contraceptive implant containing the progestogen etonogestrel (3-ketodesogestrel) for 2 years with an optional extension up to 4 years. RESULTS: Subjects were exposed to Implanon for 296.1 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding-spotting days was 10 and the median number of bleeding-spotting episodes was 2. Amenorrhea occurred in 24-39% of subject during the first 2 years and in about 20% in those who continued in the 3rd and 4th years. The most common drug-related adverse event was headache (7%). A slight increase in body mass index was observed. Only a few subjects discontinued treatment early, due to bleeding irregularities (6%) or amenorrhea (1%). The cumulative discontinuation rates were 13.4% after 2 years, 25.3% after 3 years and 28.0% after 4 years of use. Within 3 months of implant removal, six normal pregnancies occurred, indicating a rapid return of fertility. The average time taken for insertion of the implant was 0.5 min, compared with 2.5 min for removal. CONCLUSIONS: Implanon demonstrated excellent contraceptive efficacy and was well tolerated during up to 4 years of use. The vaginal bleeding pattern was variable and was characterized by relatively few bleeding events, but proved acceptable to most subjects. Because of its single-rod design, Implanon was quickly inserted and removed without complications.

The performance of levonorgestrel rod and Norplant contraceptive implants: a 5 year randomized study.

A new contraceptive (LNG rod implants, Jadelle, Leiras Oy's registered trademark for rod implants) was prospectively evaluated in randomized 5 year comparison with Norplant (Population Council's registered trademark for contraceptive implants releasing levonorgestrel) capsule implants. The study involved 1198 women at seven centres. No pregnancies occurred in the first 4 years. At 5 years, the cumulative pregnancy rate was 1 per 100 users or less for each regimen. Annual discontinuation rates averaged 11-12 per 100 users (P > 0.05), corresponding to 5 year continuation rates of 55.1 for rods and 53.0 per 100 for capsules. Mean annual discontinuation rates for menstrual disturbances were 3.5 and 4.2 per 100 for rod and capsule implants respectively (P > 0.05), and mean annual removal rates for medical problems were 3.5 and 3.0 per 100 (P > 0.05) respectively. Apart from menstrual problems, headache, weight gain and acne were the principal medical reasons for removal. In proportional hazard analyses, family formation variables, age, parity and desire/non desire for another child, recorded at admission, significantly affected discontinuation rates for major decrement categories and for all reasons combined. Mean rod removal time was half that of Norplant (P < 0.01); complications of rod removal were at a lower rate. With these contraceptives indistinguishable in performance except for ease and speed of removal, LNG rod implants appear to be preferable to Norplant for use through 5 years by virtue of relative ease of removal.

PIP: This paper presents the 5-year randomized study on the performance of levonorgestrel rod (LNG) and Norplant contraceptive implants in 1198 women in 7 centers. In the first 4 years, no pregnancies occurred. At 5 years, the cumulative pregnancy rate was 1/100 users or less for each regimen. Annual discontinuation rates averaged 11-12/100 users, corresponding to a 5-year continuation rate of 55.1/100 for rods and 53.0/100 for capsules. Mean annual discontinuation rates for menstrual disturbances were 3.5/100 for rod and 4.2/100 for capsule implants. Reasons for discontinuation of use were vaginal spotting or bleeding, irregular bleeding, headache, weight gain and acne. Proportional hazard regression models established that family formation variables, age, parity, and desire for another child, recorded at admission, significantly affected discontinuation rates for major decrement categories and for all reasons combined. Mean rod removal time was half that of Norplant. Complications of rod removal were at a lower rate. This study concludes that there is an extremely high contraceptive effectiveness for LNG rod and Norplant implants; however, LNG rod implants were more preferable than Norplant for its relative ease in removal.

Clinical performance of a new two-rod levonorgestrel contraceptive implant: a three-year randomized study with Norplant implants as controls.

In a randomized three-year clinical trial at seven clinics, the performance of levonorgestrel rod (LNG ROD) implants used by 600 women was compared with that of soft tubing NORPLANT implants used by 598 women. No pregnancies occurred in either group of women and, accordingly, body weight did not affect the efficacy of either type of implant. There were neither statistically significant nor important differences in termination rates for any reason over the three years. Complaint and illness rates during use of either of the two implant types were statistically indistinguishable and were attributable to the same set of conditions. Seventy-one per 100 of the women using each implant regimen continued to the three-year point, for an average annual continuation rate of 89 per 100. Removals of LNG ROD implants were accomplished in about half the time required for removal of Norplant capsule implants (p < 0.001).

Diagnostic laparoscopy of subfertile women of non demonstrable causes.

From 1983 to 1987, seventy-five subfertile women of non demonstrable causes in the Infertility Unit, Department of Obstetrics & Gynaecology at the Siriraj Hospital, Mahidol University had diagnostic laparoscopy. Thirty-five of seventy-five subfertile women (46.66%) had pelvic pathologies which were not suspected by clinical examination. The two common pathologies of subfertile women of non demonstrable causes were pelvic inflammatory diseases (18.6%: pelvic and peritubal adhesion) and mild endometriosis (16%). Pathophysiology of subfertile women with chronic pelvic inflammatory disease was mainly due to disturbances of tubal ovarian anatomy and function. The possible mechanism of mild endometriosis which may interfere with pregnancy was discussed in the text. The results of this study indicated that diagnostic laparoscopy should be performed in all subfertile women of non demonstrable causes to find out the pelvic pathology in order to correct the causes of infertility.

A multicentered phase III comparative clinical trial of depot-medroxyprogesterone acetate given three-monthly at doses of 100 mg or 150 mg: II. The comparison of bleeding patterns. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation Special Programme of Research, Development and Research Training in Human Reproduction.

A multicentered phase III clinical trial was conducted in seven countries to compare two dosages of depot-medroxyprogesterone acetate (DMPA), 100mg and 150mg, given every 90 days. Contraceptive efficacy and side-effects of both regimens were reported previously. Their effect on vaginal bleeding patterns is the object of this paper. A total of 1216 women were randomly assigned to a dose group and 1156 of them provided a menstrual diary. The comparison of the bleeding patterns is made using a 90-day reference period approach and following the guidelines published by WHO. In addition, the longest bleeding/spotting episode and the longest bleeding/spotting-free interval are calculated over the entire diary length. The only difference found between the two dose groups is a higher incidence of amenorrhea with the 150mg regimen. Overall, there is a high degree of consistency between the reasons given by individual women for discontinuing the contraceptive method and their vaginal bleeding pattern during the 90 days preceding discontinuation. However the data revealed large between-centre differences, both in the incidence of specific patterns, and in the identification by women of bleeding problems as reasons for discontinuation. This last point suggests that the life-table analysis underestimates the true incidence of menstrual irregularities. Comments on the reference period analysis method are made.

A multicentred phase III comparative clinical trial of depot-medroxyprogesterone acetate given three-monthly at doses of 100 mg or 150 mg: 1. Contraceptive efficacy and side effects. World Health Organization Task Force on Long-Acting Systemic Agents for Fertility Regulation. Special Programme of Research, Development and Research Training in Human Reproduction.

Two dosages of depot-medroxyprogesterone acetate (DMPA), 100 mg and 150 mg given every 90 days, were compared in two groups of women with regard to effectiveness, reported complaints and reasons for discontinuation. A total of 1216 women were recruited into a seven-centre, multinational, randomized clinical trial. Follow-up was for a period of one year and resulted in a total of 5507 woman-months of experience of 100 mg DMPA and 5429 woman-months of experience of the 150 mg dose. The study showed little difference in efficacy and side effects between the two treatment groups. Two pregnancies occurred in women receiving 100 mg DMPA giving a Pearl Index of 0.44 per 100 woman-years. None occurred in the 150 mg group. There was no difference in the overall continuation rates between the two groups at one year, being 59.3% in the 100 mg group and 58.8% in the 150 mg group. Except for discontinuation of method use for amenorrhea, the rates of all medical and non-medical reasons given for discontinuation were comparable between the two treatment groups. Women's perception of lack of bleeding was reported as amenorrhea and resulted in discontinuation rates at 12 months for amenorrhea of 7.2% for women receiving 100 mg of DMPA and 12.5% for those receiving the 150 mg dose. Three centres, Alexandria, Karachi and Szeged, made the major contributions to this difference.

A prophylactic supplementation of iron and folate in pregnancy.

The supplementation of iron and folic acid were studied in 567 pregnant women with 18 and 26 weeks of gestation. Sixty mg and 180 mg of iron were given daily to pregnant women of group I and group II respectively while 180 mg of iron and 5 mg folic acid were given to group III. The Hb values increased significantly in group II and III after supplementation for 1 1/2 months, however if supplementation was extended for 3 months, highly significant increase in Hb levels were observed in all these groups. These findings indicated that in supplementation for a shorter period, i.e. 1 1/2 months at least 180 mg of iron was needed, and only 60 mg of iron was sufficient to increase Hb levels for a supplementation of 3 months. Vitamin B12 deficiency was not detected in pregnant women both before and after supplementation with iron and iron plus folate for 3 months. It was suggested therefore that perhaps it was not necessary to supplement vitamin B12 to Thai pregnant women. In this study 15% of pregnant women had low serum folate with normal red cell folate level, and a greater number of women with low serum folate concentrations were observed after supplementation with iron alone for 3 months. However, increased serum folate and red cell folate levels after supplementation with 5 mg folic acid indicated that some pregnant women needed folate supplementation in preventing folic acid deficiency during pregnancy.

Three neuroleptanalgesia schedules for laparoscopic sterilization by electrocoagulation.

Women undergoing interval laparoscopic electrocoagulation sterilization were randomly assigned to one of three neuroleptanalgesia regimens. The 299 women received either morphine (10 mg)/droperidol (2.5 mg)/atropine (0.3 mg) or pethidine (100 mg)/droperidol (2.5 mg)/atropine (0.3 mg) or pethidine (100 mg)/droperidol (2.5 mg). A significantly higher proportion of anesthesia complications were recorded in the morphine group. The amount of pain experienced by the women was similar in the three groups, as were the rates of early follow-up complications and complaints. The neuroleptanalgesia regimen containing pethidine/droperidol/atropine appears to be the safest and most effective of the three considered here.

Pharmacokinetics of oral contraceptive steroids after morning or evening administration.

An oral contraceptive containing ethynyloestradiol and norethisterone was administered to six women in the morning and in the evening using a cross-over design. Serum levels of ethynyloestradiol and norethisterone were measured at various times after administration. There was no significant difference in a number of pharmacokinetic parameters between the two times of administration, suggesting that morning or evening administration of the contraceptive are equally effective.

PIP: An attempt was made to determine whether there were any major differences in the pharmacokinetics of the estrogen and gestagen components of a combined oral contraceptive (OC) after administration either at night or in the morning. 6 healthy volunteer females between 20-40 years of age with regular menstrual cycles were divided into 2 groups, each composed of 3 subjects. Group 1 was administered a single tablet of a combined OC at 0600 hours on day 5 or day 6 of the menstrual cycle. Group 2 was given a single tablet of the same OC at 1800 hours. 2 weeks later, Group 1 received a single tablet of the OC at 1800 hours; Group 2 was administered the OC at 0600 hours. At each study time a blood sample (10 ml) was taken from an antecubital vein prior to taking the tablet and at 0.5, 1, 2, 4, 12, and 24 hours after administration of the tablet. The blood was allowed to clot at room temperature and then centrifuged to obtain serum which was stored at -20 degrees Centigrade until analyzed. The concentrations of norethisterone and ethinylestradiol were estimated in each sample by radioimmunoassay. The OC used contained 1 mg norethisterone (NET) and 50 mcg ethinylestradiol (EE). A paired t test was used to test statistical significance between the 2 times of administration. There was no significant difference between the serum EE concentrations in the morning and evening samples taken at 2, 4, 12, and 24 hours after pill administration. For the samples taken at 0-5 and 1 hour, the concentrations in the morning samples were significantly higher than those in the evening samples. The significant differences appear to be due to a more rapid absorption of EE when the OC was given in the morning compared to the evening. In all 6 subjects the peak serum concentration was attained in less than 2 hours after morning administration of the OC. In only 3 of the 6 subjects was the peak serum concentration attained in less than 2 hours after evening administration. There were no significant differences between morning and evening administration of the OC for any of the pharmacokinetic parameters of EE. There was no significant difference between the serum NET concentrations in the morning and evening specimens at any time after OC administration. In regard to pharmacokinetic parameters for norethisterone, there were no significant differences between any of these values for morning or evening administration of OC. The study findings suggest that morning or evening administration of the OC was equally effective.

Experience with the Copper-7 and Copper-T intrauterine devices at Siriraj Hospital in Bangkok, Thailand.

PIP: A report of 2 studies focusing on the 2 year performance of Copper-7 (Cu-7) and Copper-T (Cu-T) IUDs is presented with particular reference to the characteristics of the users. 198 women had the Cu-7 IUD inserted and 200 women had the Cu-T inserted while menstruating or immediately after menstruation. In both devices, the copper wire had the same surface area. Of the sociodemographic and reproductive characteristics of the study groups, only the age and parity distributions were significantly different. The median age for the Cu-7 users was 26.8 years compared to 31.5 years for the Cu-T group. A median of 2.2 live births for the Cu-7 group is lower than for the Cu-T users (3.2 live births). Performance of the 2 devices did not differ significantly, over the study period. The net cumulative continuation rates were 68.6/100 Cu-7 users and 78.2/100 Cu-T users. At the end of 1 year, the gross cumulative pregnancy rate with the device in place was the same for both groups, .6/100 women. After 2 years, 2 additional Cu-7 users became pregnant, and the gross cumulative pregnancy rate was 2.3/100 women; the Cu-T rate remained the same. The pregnant women in the Cu-7 group were under 30 years of age. The gross cumulative expulsion rates at the end of 1 year were 5.0/100 Cu-7 users and 1.8/100 Cu-T users; after 2 years, the rates were 5.7/100 Cu-7 users and 2.5/100 Cu-T users. The majority in both groups were under 30 years old. For both groups, discontinuation of the IUDs because of pain was more frequent than for bleeding. The gross cumulative discontinuation rates of removals for bleeding/pain were 4.1/100 Cu-7 users and 2.4/100 Cu-T users at 1 year and 7.1/100 Cu-7 users and 5.7/100 Cu-T users after 2 years. 81.3% of these discontinuations occurred in women under 30 years old for the Cu-7 group compared to only 45.5% of the women discontinuing the Cu-Ts. The age-parity effect is difficult to specify due to the infrequency of events. However, younger less parous women, which was a higher proportion of the Cu-7 group, did have a higher incidence of expulsions and Cu-7 removals for pain/bleeding. The Cu-T group had a much higher proportion of women with previous IUD experience. The results suggest that the Cu-7 is as effective as the Cu-T device in minimizing the incidence of pregnancy, expulsion, and bleeding/pain removal.^ieng

Comparison of culdoscopic and laparoscopic tubal sterilization.

The growing number of women requesting interval sterilization (apart from term delivery or abortion procedures) necessitates the re-evaluation of traditional surgical procedures. A total of 800 women--the first 400 women undergoing culdoscopic and laparoscopic tubal sterilization procedures at Siriraj Hospital in Bangkok, Thailand--evaluate the appropriateness of the two sterilization procedures for use in interval sterilization programs. No serious operative complications occurred in either group. However, the rate of postoperative complications was considerably higher for the culdoscopic group than for the laparoscopic group. Hospitalization was required for only a small percentage of the patients and most had resumed their normal activities within two days of the operation. This study indicates that both procedures are effective and may be safely performed on an outpatient basis without general anesthetics and with minimal discomfort for the patients.

Use of a low-dose oral contraceptive preparation: report of a study.

PIP: A study was carried out among 100 healthy married women using the low-dose oral contraceptive (OC) Ovostat E, also known as Ovostat 28, comprised of 1.0 mg lynestrenol and 0.05 mg ethinylestradiol, and confined to the 1st 12 cycles. Patients were divided into 2 groups: 1) 35 who had never taken OCs or had discontinued 3 months prior to the study, and 2) 59 who were taking OCs prior to the study. All were seen 1 month after the initial visit and thereafter once every 3 months, and were told to record their bleeding patterns. Average age of group 1 was 24 and of group 2 was 26. All had at least 1 living child. No pregnancies occurred, bleeding patterns were not unusual although there was a high incidence (4.9%) of light breakthrough bleeding or spotting in the 1st (21.9%) and 2nd (14.6%) cycle of group 1. No significant differences in the side effects between the 2 groups was noted except for nausea (10% higher in group 1 during the 1st 4 cycles). Incidence of headache increased in group 1 but markedly decreased in group 2. Weight and blood pressure showed no significant change. At the end of the year 78 women were still on medication (others had dropped out for personal or medical reasons). In general, side effects were no different from those with normal dose OCs. Although breakthrough bleeding existed in group 1, it was mild and well tolerated and could be avoided by starting the patient on a high dose preparation a few months before starting the low dose OC. Ovostat E is found to offer increased safety resulting from the low dose of active constituents.^ieng