RESUMO

The efficacy of a low dose of mifepristone, 5 mg/day for the first 15 days of the menstrual cycle, followed by medroxy-progesterone acetate (MPA), 10 mg/day for the next 13 days, for inhibiting ovulation was assessed in ten volunteers who were treated for three successive cycles. Hormonal determinations in blood and urine samples, ovarian ultrasonography and an endometrial biopsy taken on day 21-24 of the third treatment cycle were used to monitor the cycles. Ovulation was confirmed in 11 of the 30 treated cycles and, in these 11, the LH peak and follicular rupture occurred during MPA treatment periods. Out of 19 anovulatory cycles, 16 had no increase in progesterone levels and another 3 developed a luteinized unruptured follicle. Progestin administration induced secretory changes in the endometrium, but irregular or delayed development was found. Regular withdrawal bleeding occurred in all subjects. These data indicate that the sequential regimen can suppress ovulation while maintaining regular bleeding but increased efficacy is needed for phase II clinical trials.

PIP: The efficacy of a low dose of mifepristone, 5 mg/day for the first 15 days of the menstrual cycle, followed by medroxyprogesterone acetate (MPA), 10 mg/day for the next 13 days, for inhibiting ovulation was assessed in 10 Chilean volunteers who were treated for 3 successive cycles. They were healthy, surgically sterilized women with a mean age of 36.6 years and mean weight of 58.6 kg. Hormonal determinations in blood and urine samples, ovarian ultrasonography and an endometrial biopsy taken on days 21-24 of the third treatment cycle were used to monitor the cycles. Treatment inhibited ovulation during the 3 treatment cycles in 5 women. The regimen was partially effective in 3 women and totally ineffective in another 2 women. Ovulation was confirmed in 11 of the 30 treated cycles, and, in these 11, the luteinizing (LH) peak and follicular rupture occurred during MPA treatment periods. Out of 19 anovulatory cycles, 16 had no increase in progesterone levels and another 3 developed a luteinized unruptured follicle. Among the anovulatory cycles, 3 cycles presented a biphasic hormonal profile. In these 3 cycles the luteal phase progesterone level were much lower than in baseline cycles and they were associated with unruptured follicles. The other 16 cycles had a monophasic hormonal profile with no increase in progesterone levels in spite of a delayed rise in LH level. Progestin administration induced secretory changes in the endometrium, but irregular or delayed development was found. Only 9 post-treatment cycles were followed and 5 of these were ovulatory, 1 of them without a detectable LH midcycle peak. Regular withdrawal bleeding occurred in all subjects. These data indicate that the sequential regimen can suppress ovulation while maintaining regular bleeding, but increased efficacy is needed for phase II clinical trials.

Assuntos

RESUMO

Energy, protein, lactose and fat were studied in the milk of mothers who were using different types of contraceptives. One hundred and eleven mothers made up the following groups. C: control (barrier and natural methods, or sterilization), n = 22; combined pill: LDP (low dose pill (levonorgestrel 0.15 mg + ethinylestradiol 0.03 mg)), n = 12 and MDP (medium dose pill (levonorgestrel 0.25 mg + ethinylestradiol 0.05 mg)), n = 13; MP (minipill (norethindrone 0.35 mg)), n = 37; DMPA (injectable progesterone (depot medroxiprogesterone acetate 150 mg)), n = 17; and IUD (plastic or copper intrauterine device), n = 10. The mean stages of lactation were, respectively, 15, 17, 5, 9, 5 and 9 weeks. The mean duration of observation for the study groups ranged from 2 to 4 weeks. Milk samples were collected before and after initiation of treatment (mean = 20 days; range = 14-103 days). The stage of lactation and the interval of nursing before sampling were recorded so that statistical account could be taken of these uncontrollable sources of variability. When incorporated as covariates, they showed that no significant differences existed between the groups tested, either before or after treatment.

PIP: Researchers compared data on 22 women using either a barrier method or a natural family planning method or had undergone female sterilization (controls) with data on 89 women using either a low dose combined oral contraceptive (OC), a medium dose combined OC, a low dose progestin only OC, the injectable Depo-Provera, or an IUD to examine the hormonal contraceptives' effects on the concentration of total protein, lipids, lactose, and energy in human milk. They recruited the women from private and public family planning clinics in Brasilia, Brazil between 1984 and 1987. The mean stages of lactation were 15 weeks for controls, 17 weeks for women using the combined low dose OC, 5 weeks for those using the combined medium dose OC, 5 weeks for those using the combined medium dose OC, 9 weeks for those using the low dose progestin only OC, 5 weeks for those using Depo-Provera, and 9 weeks for those using the IUD. Almost all the concentrations of total protein, lipids, lactose, and energy both before and after contraceptive therapy fell within the range for healthy women. The mean value of total protein in women using Depo-Provera was the only value higher than that range. The low dose OC was associated with a considerable increase in fat (3 g/dL vs. 4.8 g/dL; p=.035). Women taking the medium dose OC experienced a significant decrease in lactose (6.8 g/dL vs. 7.25 g.dL; p=.004). The time between last nursing and milk sample collection (nursing interval) caused considerable variation in fat (p=.03) and total energy (p=.02) in those samples collected before contraceptive therapy. When the researchers adjusted the data for stage of lactation and nursing interval from all 6 groups, the contraceptives had no significant effect on total protein, lipids, lactose, and energy.

Assuntos

RESUMO

A non-comparative study of the progestogen-only oral contraceptive, norgestrel 0.075 mg, in breast-feeding women was conducted at the Centro de Investigaciones Regionales, Merida, Yucatan, Mexico. The study was designed to evaluate the overall acceptability and contraceptive efficacy of norgestrel in breast-feeding women. This report includes a survey of 200 women, all of whom were less than 26 weeks postpartum at admission; 113 were interval patients and 87 were postpartum. Follow-up visits were scheduled at 2, 6 and 12 months after admission. Overall, women experienced an increase in intermenstrual bleeding, amenorrhea, vaginal discharge and breast discomfort. The discontinuation rate at 12 months was 32.5 and the corresponding lost to follow-up rate was 22.5; this is a measure of acceptability. The 12-month life-table rate for pregnancy was 3.4 with a standard error of 2.0. Three women discontinued use of the mini-pill due to accidental pregnancy. One pregnancy was attributed to user failure and the woman conceived 9 months after entering into the study; the other two were attributed to method failure, one woman conceived 3 months after admission and the other conceived 6 months after admission.

Assuntos

RESUMO

PIP: A postpartum contraceptive that would extend the natural infertile period would provide a good method of birth spacing. Combined oral contraceptives reduce milk volume and change its composition. Progestin-only oral contraceptives (mini-pills), Norplant, injectable progestin contraceptives, and 1-norgestrel-medicated IUDs have all been found to result in significant amounts of progestin in breast milk. A progesterone-based postpartum contraceptive appears to be the best method, but clinical trials with subdermal progesterone pellets showed that they were poorly tolerated. The National Institute of Nutrition S. Zubiran, Mexico City, is currently conducting Phase I trials of a progesterone-based injectable contraceptive that provides a steady release of progesterone over a 2-3 month period.^ieng

Assuntos

RESUMO

PIP: The authors observed the changes produced in the endometrium of 20 women who took a daily dose of 350 mcg of norethindrone uninterruptedly, starting on the 1st day of the menstrual cycle. It was found that this dose of norethindrone prevents endometrial development and the endometrium does not reach the stage of full secretion.^ieng

Assuntos

RESUMO

PIP: Progesterones and estrogens normally inhibit milk production. 50 lactating mothers, who had received no steroid since giving birth, were given daily doses of chlormadinone .5 mg from 5 to 40 days postpartum. Mothers and babies were seen every 2 weeks for 8 weeks and then every month. Milk production lasted an average of 5.7 months, with 7 women continuing from 7 to 10 months. On the average, the younger mothers produced more milk; the older ones recommenced menstruation sooner. Several supplemented their milk with other nourishment from the 2nd or 3rd month. The babies gained well, following closely the average gain, according to the Mexican Pediatric Academy. The chlormadinone was 100% effective as a contraceptive and milk production was good.^ieng

Assuntos

RESUMO

PIP: A tablet of .35 mg of norethindrone was administered daily and continuously for 6 complete cycles to 30 patients suffering from premenstrual tension syndrome and 5 suffering from functional sterility related to a deficiency of the corpus luteum. In the case of premenstrual tension, particularly good results were obtained in reducing pelvic pains, mastalgia, and headache, especially when related to disorders of the estrogen metabolism. In the sterility cases, 2 patients out of 5 responded to the treatment: 1 was in the 7th month of pregnancy at the time of writing and 1 suffered a spontaneous abortion from unknown causes in the 3rd month of pregnancy. It is concluded that this is a promising treatment, especially for premenstrual disorders.^ieng

Assuntos

RESUMO

PIP: 171 endometrium biopsies taken from 61 patients before and during treatment with daily doses of 30 mcg of d-norgestrel were studied. It was found that continuous treatment with this drug produces a number of changes in the endometrial mucus membrane, although they are less marked than those found during treatment with oral contraceptives of the combination type. The progestational effect appeared to take place earlier, and secretion began earlier, as shown by the appearance of subnuclear vacuoles. An atrophied endometrium was found in only 1 case, but this may be due to the fact that biopsies were not taken from patients showing amenorrhea. Considerable edema was frequently found in biopsies taken at all stages in the cycle. Despite the earlier appearance of the progestational effect, the development of the endometrium appeared to be less complete than in the case of normal patients without treatment. These changes may be related to the contraceptive action of d-norgestrel.^ieng

Assuntos