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PubMed1984

Depo-Provera--ethical issues in its testing and distribution.

Ethical issues relating to the use of the injectable contraceptive in developed and developing countries alike involve public policy decisions concerning both criteria for testing a new drug and individual choices about using a specific form of contraception approved for national distribution. Drug testing consists of an important but still evolving set of procedures. Depo-Provera is not qualitatively different from any other drug and some unpredictable risks are inevitable, even after extensive animal experiments and clinical trials. In assessing the risks and benefits of Depo-Provera use, epidemiological data from large-scale human use is now beginning to become more important than data from animal experiments and clinical trials. The consumer's best interest is central to any ethically responsible system of drug distribution. Systems of informed choice are needed, even in societies where illiteracy remains common and medical services are weak. In the case of a contraceptive, the risks of non-use leading to unintended pregnancy, which can result in high mortality, are relevant as well as the side-effects of the method. An attempt, therefore, is made here to categorise those issues which are universal and those which are country-specific.

Contraceptive Agents, Female↗
PubMed1984

The secretion of human chorionic gonadotropin-like substance in women employing contraceptive measures.

To study the secretion pattern of a hCG-like substance (hCG') in normal women and those employing contraceptive measures, we assayed daily urine concentrates by RIAs using an anti-hCG beta-COOH-peptide serum and an anti-hCG serum to monitor hCG' and human LH (hLH), respectively. In eight cycles of four normal women, urinary hCG' was within the normal range (less than 100 ng/day), except that four samples in two women had marginal elevations of hCG' during the menstrual or premenstrual period, but not at the time of the midcycle hLH surge. Among seven cycles from three intrauterine device (IUD) users, six showed midcycle hLH surges, and in five, hCG' was prominent (0.17-3.6 micrograms/day) in the late luteal phase. In eight cycles of women ingesting steroid contraceptives on a conventional schedule, hCG' was found during the premenstrual and menstrual intervals. The pattern of hCG' secretion was episodic, and hCG' levels were in the range of 0.3-1.8 microgram/day. It was notable that hCG' was excreted at the highest levels during intervals when ingestion of steroids was withheld. These findings suggest that contraceptive steroid hormones may modulate pituitary hCG' secretion. From gel high pressure liquid chromatographic studies, the immunoactive hCG' detected in urinary extracts from normally cycling women and IUD users had a molecular size larger than hCG beta and hLH, but was slightly smaller than hCG (lot CR119). The hCG' identified in these eluents is unlikely to be a subunit of hCG. On the other hand, the immunoactive hCG' in the urinary extracts from oral contraceptive users was mainly the hCG beta-subunit-like substance. Both hCG alpha and hCG beta immunoactive substances were heterogeneous in size in contrast to those found in normally cycling women and IUD users. In summary, the hCG' excretion pattern was different in menstrual and postmenopausal women, and hCG' identified in these subjects was heterogeneous.

Adult↗
PubMed1982

Menstruation-related periodic hypersomnia: a case study with successful treatment.

A 16-year-old girl suffered from 1 to 2-week periods of hypersomnia associated with each menstruation. Serum hormone levels were normal. CSF concentrations of homovanillic acid and 5-hydroxyindolacetic acid were lower in hypersomniac than in symptom-free phases. 3-methoxy-4-hydroxyphenylethylene glycol was not affected. The sleep periods occurred only in connection with ovulatory menstrual cycles. When ovulation was inhibited by a combination of ethinylestradiol and lynestrenol, an oral contraceptive pill, the hypersomnia ceased. Thus, the hypersomnia seemed to be linked to the occurrence of ovulatory menstruations.

Adolescent↗
PubMed1983

A randomized prospective study of the metabolic effects of four low-estrogen oral contraceptives.

Healthy, nonsmoking, normotensive, well-motivated young women were assigned at random to one of four different commercial, low-estrogen oral contraceptives. Measurements of biochemical parameters were made on two blood specimens collected from fasting subjects late in the pretreatment cycle, then again late in each treatment cycle for 12 months. All the women assigned to one product (0.5 mg norethindrone + 35 micrograms ethinyl estradiol) dropped out of the study before the end of the fifth cycle, but discontinuations with the other three products were few. Though the numbers of subjects were small, the groups were closely matched, and most of the metabolic differences were statistically significant. Products containing ethynodiol diacetate and norethindrone were associated with increases in serum total cholesterol and triglycerides but decreases in high-density-lipoprotein-cholesterol. In contrast, the levonorgestrel-containing preparation produced significantly less of an effect on these tests. A similar pattern was seen with a range of blood coagulation and fibrinolytic factors. Minimal alterations were seen with the levonorgestrel preparation, whereas those containing norethindrone or ethynodiol diacetate showed marked increases in factors I, VII, VIII and X and plasminogen, associated with a decrease in antithrombin III. Differences in the metabolic impact of the various commercially available low-estrogen preparations, combined with their effects on intermenstrual bleeding, allow a choice of the progestogen component most suitable for general use.

Adolescent↗
PubMed1983

Increased urinary androgen levels in patients with carcinoma in situ of the breast with onset while taking oral contraceptives.

Urinary testosterone, androstanediol, ethiocolanolone, and androsterone glucuronide were determined by use of gas chromatography in four patients with carcinoma in situ of the breast. In all the patients, one or more of these hormones were higher than normal. This finding supports previous reports from our laboratory of increased androgen excretion in patients with fibrocystic disease or infiltrating carcinoma of the breast. Carcinoma in situ arose while the four patients were taking oral contraceptives. The progestational component of the pill, a nonderivative of testosterone, may carry with it some androgenic properties. This fact and the discovery of increased androgen excretion levels in these four patients led us to suppose that androgens could play a role in the development of breast cancer.

Adolescent↗
PubMed1987

Pregnancy after removal of Norplant implants contraceptive.

Many concerns have been expressed regarding the introduction of a new contraceptive method into family planning programmes. One of the concerns is the return of fertility after discontinuing the method. To evaluate the subsequent fertility status of the Indonesian women after removal of Norplant, a prospective longitudinal study was undertaken in Klinik Radeb Saleh, Jakarta. Fifty-one women whose Norplant were removed because of their wish to become pregnant were followed-up for a period of two years or until pregnancy occurred, whichever was earlier. Two groups of women who had Lippes C IUD removed or discontinued the use of DMPA for planning pregnancy served as control and were followed-up for equal length of time. The cumulative conception rate for ex-Norplant users, ex-IUD users and ex-DMPA users at one year was 76.5, 74.7 and 70.2 per 100 women, respectively. There was no significant difference between the groups (p greater than 0.05). The present study, along with other studies, indicate that the prolonged use of Norplant do not impair the return of fertility.

Adult↗
PubMed1989

Lipid and lipoprotein changes in women taking low-dose, triphasic oral contraceptives: a controlled, comparative, 12-month clinical trial.

Effects on lipid/lipoprotein metabolism of two triphasic oral contraceptives, Triphasil (ethinyl estradiol/levonorgestrel) and Ortho-Novum 7/7/7 (ethinyl estradiol/norethindrone) were compared in a 12-month controlled, prospective clinical trial. The data indicate that use of both estrogen-progestin preparations were accompanied by increases in cholesterol, low-density lipoprotein and high-density lipoprotein3 cholesterol, apolipoproteins A1 and B, and triglycerides. Also observed were a decline in high-density lipoprotein cholesterol and greater decreases in high-density lipoprotein2 cholesterol levels; the latter were below the lower limits of laboratory's reference range. All other changes remained within clinically acceptable limits. There were no statistically significant differences between the test preparations, suggesting that the impact on lipid metabolism of the triphasic preparations Triphasil and Ortho-Novum 7/7/7 are similar and, given the dynamic balance between the various fractions, are unlikely to impart an adverse cardiovascular risk.

Adult↗
PubMed1982

Metabolic effects of the triphasic oral contraceptive Trigynon.

Effects of Trigynon, a triphase low-dose oral contraceptive, containing ethinylestradiol and l-norgestrel in various proportions, on testosterone binding globulin, transcortin, thyroxine, free testosterone, free cortisol and free thyroxine as well as on plasma lipids and glucose tolerance were studied in 12 normal women treated for 3-6 months. Trigynon appears to have dominant estrogenic effects as evidenced from the increase in transport proteins and the decrease in free testosterone concentration. Plasma lipids were not significantly influenced; glucose tolerance was slightly, but not significantly decreased.

Adult↗
PubMed1983

Oral contraceptive steroids do not promote the development or growth of prolactinomas.

Seventy women with prolactinomas, age 19-38 years, were studied in order to evaluate a possible relationship between the use of steroidal oral contraceptives (o.c.) and the development of prolactin-producing adenomas. Sixty-seven patients were admitted for investigation because of menstrual bleeding disturbances and three patients because of galactorrhea. Forty-three patients (61%) had used o.c. Thirty-six out of forty-three women (83%) experienced their menstrual disturbances and/or galactorrhea when using o.c. or immediately after discontinuing the pill. Patients who had used o.c. had shorter duration of symptoms, lower S-prolactin levels and less pronounced enlargement of the sella turcica. These tendencies indicate that o.c. lead to an earlier manifestation of clinically latent prolactin-producing tumours. With or without previous o.c., the patients showed a low total fertility rate, indicating a notably long, clinically undiagnosed period of disease. The accumulated usage of o.c. by the women with prolactinomas was not higher than among the total female population of the same age in Sweden. Furthermore, patients on o.c. for several years did not show a more advanced form of the disease than women who had not taken the pill. Thus, the present study provides no support for the hypothesis that o.c. promote the growth of prolactin-producing pituitary adenomas.

Adenoma↗
PubMed1984

Return of ovulation and fertility in women using norethisterone oenanthate.

The return of ovarian activity was studied in 20 women who had discontinued norethisterone oenanthate after using the injectable contraceptive for 6 months to 5 years. Follicular activity returned within 70 days of discontinuing in four women and within 90 days in a further seven. In only 4 women was the return of follicular activity associated with a rise in the serum progesterone level. The serum norethisterone concentration was usually less than 1 ng/ml at the time of return of ovarian activity and was lower in women in whom ovarian activity returned before day 90 than in those in whom it returned after day 90. Of 40 women who discontinued norethisterone oenanthate, pregnancy occurred in 14 women within 12 weeks of discontinuing and in 21 (52.5%) within 6 months. The findings suggest that there is no impairment of fertility in women using norethisterone oenanthate.

Adult↗
PubMed1986

Bioequivalence of norethindrone and ethinyl estradiol for two different weight tablets with the same hormonal content.

Two tablets of differing weights, 100 mg (A) and 50 mg (B), of an oral contraceptive drug (OC) were compared with each other and to a solution (C) of the same components. The composition of the OC consisted of 1 mg of norethindrone (NET) and 0.035 mg of ethinyl estradiol (EE2). Both tablets were shown to differ from the solution, which was more rapidly absorbed, but were not significantly different from each other. Formulation means for NET and EE2, for each of the two products, were similar. Application of an interval test for the ratio of computed parameters demonstrated equivalence of the two formulations with respect to 0-24 hr area under the curve (AUC24) and total area under the curve (AUC+o+) for both NET and EE2 and with respect to concentration maximum (Cmax) for EE2. The data support the hypothesis for bioequivalence of the two formulations with respect to total absorption.

Absorption↗
PubMed1987

Clinical performance of a levonorgestrel-releasing intracervical contraceptive device during the first year of use.

One-hundred-and-ninety-eight women used a new type of levonorgestrel-releasing intracervical contraceptive device (LNG-ICD) designed to release 20 micrograms levonorgestrel/day. The insertion took place within 7 days of menstruation. Clinical performance during the first year of LNG-ICD use was evaluated. Seven pregnancies occurred during the study period; one in an epileptic woman using carbamazepine, 300 mg/day, and the other six in healthy women after unnoticed expulsion of the ICD. Sixteen spontaneous expulsions occurred. The most common reasons for removal were side effects, including bleeding disturbances, hormonal side effects and other medical reasons. The continuation rate was 72.6 per cent after one year. Three pelvic infections were observed.

Adult↗
PubMed1988

Lack of metabolic effects of a triphasic formulation containing norethindrone in normal women studied prospectively.

The glucose and insulin responses to oral glucose tolerance tests and lipid values in normal women taking a triphasic pill containing norethindrone (Ortho 7/7/7) were performed. After three months, no significant changes in these metabolic indices were found. These results confirm and expand the knowledge regarding the metabolic safety of norethindrone-containing triphasic formulations.

Adult↗