Effectiveness of Cyclofem in the treatment of depot medroxyprogesterone acetate induced amenorrhea.

A total of 100 women who were using depot medroxyprogesterone acetate (DMPA) for contraception and who had experienced at least 6 months of drug induced amenorrhea, were randomized to either switching their method of contraception to Cyclofem, or continuing with DMPA. At the end of 6 months, 82% of the Cyclofem users had experienced some vaginal bleeding, compared with 10% of DMPA users. Time to resumption of vaginal bleeding was related to the duration of DMPA use to the duration of DMPA induced amenorrhea, and to the body mass index of the user. Over the 6 months of follow-up, 94% of Cyclofem users complained of some side effects, compared with 22% of DMPA users. The most frequently cited problems among Cyclofem users included breast tenderness, abdominal pain, and dysmenorrhea; yet a third of these women opted to stay on Cyclofem at the end of the study. It is concluded that switching to Cyclofem is a new option for DMPA users who are concerned about amenorrhea. Although using Cyclofem in this setting will not meet the needs of all such women, its effectiveness in inducing vaginal bleeding justifies a trial in those who have no contraindication to estrogen treatment.

PIP: Substantial numbers of women experience amenorrhea while using the injectable contraceptive depot medroxyprogesterone acetate (DMPA) and this represents a major cause of method discontinuation. In the present study, 100 DMPA acceptors from Bangkok, Thailand, with a history of at least 6 months of drug-induced amenorrhea were randomly assigned to switch their contraceptive method to Cyclofem (a combination of 25 mg of DMPA and 5 mg of estradiol cypionate) or continue with DMPA (150 mg). After 6 months, 82% of Cyclofem users compared with only 10% of DMPA users had experienced some vaginal bleeding. The median time to resumption of vaginal bleeding was 8 weeks in the Cyclofem group. Resumption time was related to the duration of DMPA use, the duration of DMPA-induced amenorrhea, and the user's body mass index. Although 94% of Cyclofem users compared with only 22% of DMPA users experienced minor side effects (breast tenderness, abdominal pain, dysmenorrhea) during the 6-month study period, 34% of these women elected to remain on Cyclofem at the end of the study. On the other hand, 90% of DMPA users opted to continue method use despite amenorrhea. The proven efficacy of Cyclofem justifies a trial in DMPA users concerned about their amenorrhea. This regimen can be expected to induce vaginal bleeding in more than 80% of users after 1-3 months of treatment.

Levonorgestrel concentrations during use of levonorgestrel rod (LNG ROD) implants.

In a three-year randomized trial that included 398 women, blood samples were collected for the purpose of assaying levonorgestrel concentrations in women using a new two-rod contraceptive implant system or an earlier implant formulation, Norplant-2 implants. Sample collection was at 1, 3, 6, 9, and 12 months after placement and semiannually thereafter through three years. Resulting assays and analyses showed that levonorgestrel concentrations of each implant formulation decreased significantly with time after placement, with increasing body weight, and with ponderal index. In the third year, several measures indicated that concentrations of the contraceptive drug were higher in women using the LNG ROD implants than in users of the original formulation. No pregnancies occurred among women in either group in the three years. This study provides evidence that the minimum levonorgestrel concentration needed to protect against pregnancy is below 200 pg/ml, and possibly is below 175 pg/ml.

Sexual maturation in Thai girls.

Generally, menarche is considered an indicator of girls' sexual maturation. In Thailand, this study on the menarcheal age in female pupils was conducted in Bangkok, and the central, northern, northeastern and southern regions of Thailand, which differ in their geography, tradition and customs. In carrying out the research, 8,200 questionnaires were distributed to female pupils aged 10-17 years. The result was that the mean menarcheal age was 12.3 years. For the length of menstrual period, it was found that 83.7 per cent had a period of less than 7 days and 75.7 per cent used 2-4 pieces of sanitary napkins per day. For the regularity of menstrual period, 48.5 per cent had a regular period and 41.8 per cent had a period once within 2 months. For the persons whom these female pupils needed for advice about menarche, the study indicated that mothers were mostly needed. For the mean menarcheal age reported in each region, it was found that in the central region the mean menarcheal age was 12.5 years, the North was 12 years, the Northeast was 12.4 years and the South was 12.7 years. These data prove to be statistically significant, that is the lowest menarcheal age of female pupils was in the North while the highest was in the South. In terms of nature and characteristics of female pupils' menstruation in 4 regions there was no difference. When comparing the BMI value of female pupils already having a period in each region, the result was that there was no difference. The BMI value of those already having a period was higher than those not having had a period; and in the latter group, the BMI value of female pupils in the North was the highest while that in the Central region was higher than in the Northeast and the South.

PIP: Generally, menarche is considered an indicator of girls' sexual maturation. In Thailand, this study on the menarcheal age in female pupils was conducted in Bangkok, and in the central, northern, northeastern, and southern regions of Thailand, which differ in their geography, traditions, and customs. 8200 questionnaires were distributed to female pupils aged 10-17 years. Mean menarcheal age was found to be 12.3 years. Concerning the menstrual period, it was found that 83.7% had a period of less than 7 days and that 75.7% used 2-4 sanitary napkins per day. Concerning the regularity of the menstrual period, 48.5% had a regular period and 41.8% had their period once within 2 months. Concerning the persons from whom these female pupils sought advice about menarche, the study indicated that mothers were most frequently consulted. Concerning mean menarcheal age, it was found that in the central region it was 12.5 years, in the north it was 12 years, in the northeast it was 12.4 years, and in the south it was 12.7 years. These data prove to be statistically significant; that is, the lowest menarcheal age was found in the north while the highest was found in the south. In terms of the nature and characteristics of female pupils' menstruation in the four regions, there was no difference. When comparing the BMI value of female pupils already having periods in each region, no difference was found. The BMI value of those already having periods was higher than those who had not yet had a period; and, in the latter group, the BMI value of female pupils in the north was the highest, while that in the central region was higher than that in the northeast and the south.

Past and current STDs in a Thai adolescent population.

The study of premarital sexual intercourse in 350 Thai students aged 18-20 years in commercial schools showed that 151 subjects (43.1%) having premarital sexual intercourse--50.3 per cent never used condoms, 25.8 per cent used sometimes and 23.8 per cent used everytime. Their sexual partners were girl friends in 78.1 per cent and sex workers in 18.5 per cent. The average age of first sexual intercourse was 16.6 years. There were 87 subjects who had symptoms similar to sexually transmitted diseases. Single void-urine was tested for past and present C. trachomatis infection. There were 8 of 350 subjects (2.3%) with positive results for the leukocyte esterase activity in urine samples but only 2 cases (0.6%) were positive for C. trachomatis antigen and antibody. Detection of C. trachomatis DNA was negative in all urine samples. The antibody detection in urine samples was 11.1 per cent and in blood samples 22 per cent. There was no correlation with r = 0.3 of optical density values between urine and blood samples.

Outcome of pregnancy in the presence of intrauterine device.

The outcome of 196 pregnancies with Lippes Loop in situ was studied. In 102 cases with inaccessible thread, the IUD was left in place. Ninety-four women had the IUD removed when the thread was still visible. The incidence of spontaneous abortion and premature delivery was 56.8% in the group of 102, and was significantly higher than in those women whose loop was removed. No serious complications occurred in any of the cases. The results suggested that the IUD should be removed early in pregnancy when the string is still accessible.

PIP: 196 cases of confirmed intrauterine pregnancy with an IUD in place were followed up. The 94 women whose IUD thread was still visible had the device removed. In 102 cases the thread was inaccessible and the IUD was allowed to remain. Visibility of the thread seemed to depend on the gestational period, with 98% of women seen at 8 or less weeks of pregnancy having a visible thread and only 2.1% of the cases seen after 9-12 weeks of pregnancy. Spontaneous abortion or premature delivery occurred in more than 1/2 the women who continued their pregnancies with the IUD remaining in place. This was a significantly higher rate than for the women whose IUDs were removed. No serious complications resulted in any of the 196 cases. Results of the study suggest that, if a pregnancy occurs with an IUD in place, the IUD should be removed as soon as possible if the string remains visible.

Birth control counseling for HIV seropositive pregnant women.

Testing for HIV antibody at the antenatal clinic in Siriraj Hospital started on 1 July 1991. It was found that the percentage of HIV seropositive pregnant women rapidly increased from 1.2% in 1992 to 1.9% in 1993. During those 2 years, 487 seropositive women were admitted for delivery or abortion; 23.8% were adolescents and 47.0%, young adults. Prevention of HIV transmission from mother-to-baby was birth control; 95 women (19.5%) chose to abort their pregnancy. After termination of all pregnancies by abortion or delivery, 83% requested sterilization, 12.9% accepted Norplant, 1.8% the pill and only 2.3% refused anything at all. Condoms were used regularly for prevention of HIV infection by 29.4% of men although Thai men generally do not accept them for birth control. Seropositive Norplant users had more bleeding than general Norplant users but treatments were the same.

Clinical evaluation of the therapeutic effectiveness of ethinyl oestradiol and oestrone sulphate on prolonged bleeding in women using depot medroxyprogesterone acetate for contraception. World Health Organization, Special Programme of Research, Development and Research Training in Human Reproduction, Task Force on Long-acting Systemic Agents for Fertility Regulation.

A placebo-controlled randomized clinical trial was conducted in six centres to compare the effects of a 14 day treatment with either 50 micrograms ethinyl oestradiol daily or 2.5 mg oestrone sulphate daily, on depot medroxyprogesterone acetate (DMPA)-induced prolonged bleeding. Out of 1035 women admitted to the study, 278 requested treatment and were given ethinyl oestradiol (n = 90), oestrone sulphate (n = 91) or placebo (n = 97). Ethinyl oestradiol was successful in stopping the bleeding episode in 93% of cases, compared with oestrone sulphate and placebo which had success rates of 76 and 74% respectively. However, the relative advantage of ethinyl oestradiol was marginal, with an average reduction of 1 bleeding day and 3 spotting days compared with the other two groups. Immediately after treatment, women given ethinyl oestradiol had less bleeding but a more unpredictable pattern than the other two groups. In the long term, there were no differences between the bleeding patterns or the discontinuation rates for any reason in the three groups, and the most important single reason for discontinuation in those groups remained 'menstrual problems'. In summary, the study showed that treatment of DMPA-induced prolonged bleeding with ethinyl oestradiol had a limited short-term effect but no beneficial effect on the acceptability of DMPA as a contraceptive method. Treatment with oestrone sulphate was no different from placebo.

PIP: The findings of a multicenter clinical trial challenge the practice of estrogen treatment of the prolonged or irregular vaginal bleeding associated with depot medroxyprogesterone acetate (DMPA) contraceptive use. Included in the study were 1035 DMPA users (mean age, 27 years) from Alexandria, Egypt; Bangkok, Thailand; Chiang Mai, Thailand; Jakarta, Indonesia; Karachi, Pakistan; and Manila, Philippines. 456 (44%) of these women experienced a bleeding episode lasting more than 7 days during their first 6 months of DMPA use. Of these, only 278 (61%) requested treatment. These 278 women were randomly allocated to receive 50 mcg of ethinyl estradiol (n = 90), 2.5 mg of estrone sulfate (n = 91), or placebo (n = 97) daily for 14 days. The treatment stopped the bleeding episode for 93% of women in the ethinyl estradiol group, 76% of those in the estrone sulfate group, and 74% of women receiving a placebo. The ethinyl estradiol advantage was marginal, however. On average, women treated with ethinyl estradiol had their bleeding episode shortened by 1 bleeding day and 3 spotting days. Immediately after treatment, women given ethinyl estradiol had less bleeding and spotting days than their counterparts in the 2 other groups, but demonstrated a more unpredictable pattern, including a greater range of lengths of bleeding/spotting-free intervals. Three months after treatment, there were no differences between the 3 groups in vaginal bleeding patterns.