A comparative study of a progestin-only oral contraceptive versus non-hormonal methods in lactating women in Buenos Aires, Argentina.

A non-randomized comparative clinical trial of the progestin-only oral contraceptive (POC), Ovrette (75 mcg norgestrel) (Wyeth), versus non-hormonal methods was conducted at two clinics in Buenos Aires, Argentina. The trial was designed to assess the breast-feeding patterns of women choosing progestin-only oral contraception and non-hormonal methods of contraception, and to study the relationship between lactation and the clinical performance of a POC. Five-hundred women were allocated to either the progestin-only pill group (n = 250) or to the non-hormonal group (n = 250) and were followed up monthly for six months after admission. Measurements in mean infant weight, mean infant length, and mean head circumference were similar throughout the follow-up period. Non-hormonal users reported significantly more self-perceived decreases in milk production at the 5th and 6th month follow-up intervals. Acceptance and continued use of the pill were excellent, with only one woman discontinuing because of a pregnancy which was attributed to user failure. The principal side effect reported by women in both groups was intermenstrual bleeding.

PIP: A nonrandomized, comparative, clinical trial of the progestin only oral contraceptive (OC) Ovrette (75 mcg norgestrel) vs. nonhormonal methods was conducted at 2 clinics in Buenos Aires, Argentina. The trial was designed to assess breast-feeding patterns of women choosing progestin- only OCs and nonhormonal methods of contraception and to study the relationship between lactation and the clinical performance of the OC. 500 women were allocated to either the progestin-only pill group (n=250) or t o the nonhormonal group (n=250) and were followed monthly for 6 months after admission. Measurements in mean infant weight, mean infant length, and mean head circumference were similar throughout the follow- up period. Nonhormonal users reported significantly more self-perceived decreases in milk production at the 5th an 6th month follow-up intervals. Acceptance and continued use of the pill were excellent, with only 1 women discontinuing because of a pregnancy which was the result of user failure. The principal side effect reported by women in both groups was intermenstrual bleeding.

The effects of a progestin-only oral contraceptive (levonorgestrel 0.03 mg) on breast-feeding.

This study was a non-randomized clinical trial which compared the breast-feeding experience of 250 Argentine women taking levonorgestrel 0.03 mg daily (begun one week after delivery) with that of 250 women using non-hormonal contraceptives. Weight gain of unsupplemented infants, the most important of the several criteria used to assess breast-feeding performance, was similar for the two contraceptive groups. Levonorgestrel users began supplementary feeding of their infants significantly later than did non-hormonal users; levonorgestrel users were also somewhat less likely to discontinue breast-feeding during the study period. The two contraceptive groups were similar with regard to several other measures of breast-feeding performance: growth of all infants (regardless of supplementation), patterns of contraceptive discontinuation, mothers' subjective impressions of breast-milk sufficiency, and comparison of supplementation initiation with previous experience.

PIP: This study was a non-randomized clinical trial which compared the breast-feeding experience of 250 Argentine women taking levonorgestrel 0.03mg daily (begun one week after delivery) with that of 250 women using non-hormonal contraceptives. Weight gain of unsupplemented infants, the most important of the several criteria used to assess breast-feeding performance, was similar for the 2 contraceptive groups. Levonorgestrel users began supplementary feeding of their infants significantly later than did non-hormonal users; levonorgestrel users were also somewhat less likely to discontinue breast-feeding during the study period. The 2 contraceptive groups were similar with regard to several other measures of breast-feeding performance; growth of all infants (regardless of supplementation), patterns of contraceptive discontinuation, mothers' subjective impressions of breast-milk sufficiency, and comparison of supplementation initiation with previous experience.

Contraception with levonorgestrel, 0.15 mg, and ethinyl estradiol, 0.03 mg. Clinical studies in Latin America.

Levonorgestrel, 0.15 mg, and ethinyl estradiol, 0.03 mg, an ultra-low-dose oral contraceptive product, was studied in Latin America. In total, 1,206 sexually active, fertile women in their reproductive years were followed through 9,736 cycles. Only one of eight pregnancies was attributed to failure of the medication, resulting in a corrected Pearl index of 0.13. Very good cycle regulation was achieved, with an acceptably low rate of intermenstrual bleeding. The medication was discontinued for medical reasons in only 5% of the patients. Apart from a mild case of thrombophlebitis, there were no major side effects. These studies show that this combination oral contraceptive provides effective contraception with a very low incidence of side effects.

PIP: 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, an ultra-low-dose oral contraceptive (OC) was studied in Latin America. In total, 1206 sexually active, fertile women in their reproductive years were followed through 9736 cycles. Only 1 of 8 pregnancies was attributed to failure of the medication, resulting in a corrected Pearl Index of 0.13. Very good cycle regulation was achieved, with an acceptably low rate of intermenstrual bleeding. The medication was discontinued for medical reasons in only 5% of the patients. Apart from a mild case of thrombophlebitis, there were no major side effects. These studies show that this combination OC provides effective contraception with a very low incidence of side effects.

Further experience with quingestanol acetate as a postcoital oral contraceptive.

PIP: The experiences of 4 clinical research groups, 1 each in Mexico, Peru, Chile, and Argentina, using quingestanol acetate as a postcoital oral contraceptive is described. 2702 patients accumulated 18,531 cycles of postcoital therapy. In Mexico with a 800 mcg dose, the pregnancy rate was .6. In Chile and Peru at a dose of 750 mcg, pregnancy rates were over 20. Differences in selection of patients may account for part of the difference.^ieng

Evaluation of the contraceptive efficacy of quingestanol acetate (W 4540) when administered as an oral low-dose conraceptive in the puerperium.

PIP: 652 women (80% postpartum) who received 300 mcg daily doses of quingestanol acetate (W 4540) for an average of 9.6 cycles were observed during a 3-year study conducted by Ramon Sarda Maternal and Children's Hospital of Buenos Aires. Of 16 pregnancies, 6 were attributed to drug failure for a rate of 3.1/100 woman-years. It was found that menstrual cycle length, duration, and amount of flow were consistent with normal cycles. Amenorrhea was observed in 65% of the patients and in 24% of the cycles. 35% of all patients had at least 1 case of intermenstrual bleeding. Spotting was reported in 32% of the patients and in 6% of the cycles. Except for headaches (8% of the cases, 2% of total cycles) no significant side effects were experienced. 92% of the women are still on treatment. Quingestanol acetate (300 mcg daily) was found to be clinically safe and effective for postpartum patients.^ieng