Effect of long-acting progestagen-only injectable contraceptives on carbohydrate metabolism and its hormonal profile.

Two groups, each composed of 20 women, who used depomedroxyprogesterone acetate (DMPA) or norethisterone enanthate (NET-EN) injectable contraceptives were investigated for changes in 75-g OGTT and in the fasting and two-hour post oral glucose load (2-hours) levels of serum insulin, growth hormone, glucagon, cortisol and blood pyruvate. Samples were taken before and 3, 6 and 12 months after use of injectables. DMPA and NET-EN caused significant changes in mean blood glucose and pyruvate and in mean serum insulin, growth hormone and glucagon, but not in mean fasting cortisol. Changes with NET-EN started after 3 months, became maximal after 6 months and reverted to normal after 12 months of use, due to more frequent administration during the first 6 months of use (every 60 +/- 5 days) and to more spacing of the injections (every 84 +/- 5 days) after that. Changes with DMPA started after 3 months, and increased with the duration of use to become maximal after 12 months. Maximal changes were similar with DMPA and NET-EN and consisted of: a significant increase in fasting blood glucose and pyruvate and serum insulin; a significant increase in 2-hour blood glucose and pyruvate, serum insulin, growth hormone and glucagon. Although significant changes in blood glucose levels occurred with both DMPA and NET-EN, yet they did not reach the lower cut-off levels for impaired glucose tolerance in any user. With the same spacing of injections, i.e. every 84 +/- 5 days for NET-EN and every 90 +/- 5 days for DMPA, the effects on various parameters studied were less with NET-EN.

Acceptability of injectable contraceptives in Assiut, Egypt.

The present work was a randomized comparative study of two injectable progestogen-only contraceptives. The first group (200 subjects) received 150 mg of depotmedroxyprogesterone acetate (Depoprovera) every 84 +/- 7 days and the second (200 subjects) received 200 mg of norethisterone enanthate (Noristerat) every 56 +/- 7 days. Acceptors of injectable contraceptives in Assiut, Egypt, were mainly women looking for fertility termination. Menstrual disruption was the main side effect among both treatment groups. Amenorrhoea was the commonest menstrual complaint and was the main reason for discontinuation in both groups. Only one pregnancy occurred during NET-EN use; two more pregnancies occurred, one in each of the two groups but there were indications that conception preceded the first injection. Menstrual irregularities were generally more frequent with DMPA users. However, DMPA had better one-year continuation rates than NET-EN (68.8 +/- 3.5 and 57.1 +/- 3.6 per 100 women, respectively).

Testing times for women in body lab.

PIP: The Australian Drug Evaluation Committee (ADEC) has never approved Depo-Provera for general use as a contraceptive, but it is approved for the treatment of malignant neoplasia and precocious puberty. Thus, it is available on the drug market. On the market, the drug is being used as a contraceptive under guidelines issued by the ADEC. The guidelines allow the drug to be prescribed as a contraceptive for investigational purposes on the basis of informed consent. The practical effect of this is that doctors are the final arbiters of its use. Evidence exists that Depo-Provera is being given to disadvantaged women in Australia and overseas without their informed consent. Attention has been focused on this medical practice and on the contraceptive itself. Its erratic use for contraception in Australia has attracted the critical gaze of 2 federal ministries. Meanwhile the drug continues to be prescribed as a contraceptive in Australia even though the ADEC, following the lead set by the US Food and Drug Administration (FDA), has not given its approval. Although not approved in the US, Depo-Provera is approved as a contraceptive in about 80 countries. In New Zealand the drug was approved as early as 1968 and now has a higher per capita use in that country than any other in the world. In January this year, as a result of an appeal by Upjohn Pty Limited against the FDA's earlier refusal to approve the drug, Depo-Provera became the subject of the 2nd only public Board of Inquiry convened by the FDA. The results of that inquiry will not be known for several months. The lineup at the inquiry reflected the pattern of opposing forces wherever the drug has been debated. An impressive array of health experts and organizations appeared in favor of approval. Those arguing for disapproval included the FDA scientists themselves, the Public Citizens Health Research Group, and the National Women's Health Network. The key scientific issue in the inquiry involved the validity of animal studies on the drug. The drug company argued that the beagle dog, which had developed breast tumors when tested with the drug, was not an appropriate model for judging the effects of the drug in humans, a view shared by the World Health Organization (WHO). FDA scientists and the medical director of the health research group argued that even if dogs and monkeys do not exactly mimic effects on humans, animal studies are a reliable predictor of carcinogenicity in humans. Even if the FDA was to approve the drug and if the Australian government was to follow suit, consumer groups and women's health groups would be expected to use such an inquiry to press for longterm monitoring of the drug and standard guidelines for informed consent.^ieng