ABSTRACT
Bioabsorbable implants prepared by fusion of 85% norethisterone (NET) and 15% cholesterol were inserted subdermally in four cycling bonnet monkeys (Macaca radiata). No skin reaction or inflammation was observed at the site of implantation. Plasma concentration of norethisterone (NET) measured by radioimmunoassay were monitored for 14 to 16 months at monthly intervals. In the first month weekly samples were analysed. NET was released into circulation within 24 hours after insertion of the implant. In all the monkeys, except one, a sharp rise in NET (1.9 to 20 ng/ml) occurred immediately after insertion. Levels then remained between 1.7 and 0.6 ng/ml for about 4 months. Thereafter they remained steady up to about 9 months in two monkeys and gradually declined to about 0.4 ng/ml in the remaining two. In all except one, there was a sudden burst of NET release between the 10th and 11th month. The hormone almost cleared out of circulation by the 14th to 16th month. Initial menstrual cycles after pellet insertion were disturbed, leading to spotting and irregular bleeding. Regular cycles appeared from 5 to 8 months after the insertion of the implant. These cycles were ovulatory, as determined by the progesterone levels.
Subject(s)
Norethindrone/pharmacology , Animals , Drug Implants/adverse effects , Female , Haplorhini , Inflammation/etiology , Macaca radiata , Menstruation/drug effects , Norethindrone/administration & dosage , Norethindrone/blood , Progesterone/bloodABSTRACT
The Indian Council of Medical Research conducted a multicentric trial with a single vaginal suppository containing 3 mg 15-Me-PGF2 alpha for terminating pregnancies. Success rate in the 290 women investigated was 79.2 per cent at 30 hours observation. The mean induction-abortion interval was 14.7 hours and the incidence of complete abortions was 58.3 per cent. Vomiting and diarrhoea were the most common side-effects noted. Vomiting was experienced by 72.3 per cent women and diarrhoea by 76.8 per cent. Although the vaginal route for administering 15-Me-PGF2 alpha is simple and the induction-abortion interval short, it is suggested that the combination of a vaginal suppository and prostaglandins intra-muscularly may lead to higher percentage of complete abortions.
Subject(s)
Abortion, Induced , Prostaglandins F/pharmacology , Adult , Female , Humans , Pregnancy , Pregnancy Trimester, First , Pregnancy Trimester, Second , Prostaglandins F/administration & dosage , Prostaglandins F/adverse effects , SuppositoriesABSTRACT
The Indian Council of Medical Research initiated a multicentric trial with prostaglandins in 1976 to assess the safety and efficacy of their use in midtrimester abortions. PGF2 alpha and 15-Me-PGF2 alpha were compared using the intra-amniotic (I.A.) route. 15-Me-PGF2 alpha was also evaluated by extra-amniotic (E.A.) route. With intra-amniotic instillation, success rate was 88.1 per cent with PGF2 alpha and 93.0 per cent with 15-Me-PGF2 alpha within 48 hours and by the extra-amniotic route it was 78.1 per cent within 36 hours. The mean induction-abortion interval was 19 hours with I.A. and 14.8 hours with E.A. Abortions were complete in 48.8 per cent of the women following I.A. PGF2 alpha, 56.0 per cent following I.A. 15-Me-PGF2 alpha and only 23.0 per cent following E.A. administration. Vomiting and diarrhoea were the most commonly reported side effects. Cervical injuries were 4.7 per cent with I.A. PGF2 alpha, 1.4 per cent with I.A. 15-Me-PGF2 alpha and only 0.6 per cent with E.A. route.
