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Intrauterine contraception with Nova-T and copper-T-200 during three years.

A randomized comparative trial on the clinical performance of two copper-releasing IUDs (Nova-T and Copper-T-200) was performed simultaneously in Denmark, Finland and Sweden. After three years the cumulative pregnancy rate was 1.9 for Nova-T and 5.0 for Copper-T. This difference in efficacy was statistically significant (p less than 0.001). Copper-T had a lower expulsion rate (p less than 0.05) in the total series but not in postmenstrual insertions. Differences between the two devices in other termination rates were not statistically significant. Analysis according to age and parity demonstrated that the pregnancy rate of Nova-T was lower than that of Copper-T in every age and parity group. The pregnancy rate of Nova-T was not effected by age or parity whereas the pregnancy rate and the expulsion rate of Copper-T decreased with increasing age and parity. The removal rate because of infection decreased markedly after the first year of use for both devices. The cumulative rate of removals for infection during the three years of use was not significantly correlated to age and there was no correlation to parity. The continuation rates increased with age and parity. The continuation rates of nulli- and primiparous women were almost identical with both devices and lower than continuation rates of women with 2 or three or more children. Only 11% of the women were lost to follow-up during 36 months. Nova-T had superior effectiveness in preventing undesired pregnancies when compared with Copper-T. The performance of Nova-T is less affected by age and parity then the performance of Copper-T. The silver core in copper wire gives a prolongation of the life-span for Nova-T. For these reasons, Nova-T appears to meet the requirements for an ideal IUD.

Adult↗

Introducing the low-dose pill to Bangladesh; issues of continuation and failure.

In response to government plans to introduce a low-dose pill to the national family planning program of Bangladesh, a comparison of the performance of low-dose and standard-dose pills among a rural Bangladeshi population was conducted. Continuation rates were found to be better among users of the low-dose pill and there was no evidence that failure rates were higher. The relative risk (standard-dose vs. low-dose) over the first 30 months following adoption was 1.25 for first method continuation, and 1.29 for extended use failure. This paper, thus, provides evidence that low-dose pills may be a suitable method of contraception for rural Bangladeshi women.

Adult↗

Five years private practice experience of nulliparous women using copper IUD's.

This is a study of 296 nulliparous women who used Copper IUD's as their method of contraception. At the time of first insertion the women had an average age of 21.6 years. The gross cumulative pregnancy rate rose to 11.8 over 5 years. The gross cumulative expulsion rate rose to 13.6 over 5 years and the removal rate for bleeding and pain to 20.4. The net rates were lower over 5 years (pregnancy 8.6, expulsion 11.2 and bleeding and pain 17.3). 29 women expelled their IUD's, of whom 20 underwent reinsertion. 43 women requested removal of their IUD's because of bleeding and pain, of whom 6 requested a reinsertion at a later date. Taking reinsertions into account, the continuation rate over 5 years was 55.2. Inability to insert the IUD was encountered in 28 women (8.6%). In 20 of the women cervical stenosis precluded the insertion of the IUD without local anesthetic, and in the other 8, the pain and/or syncope encountered during sounding the uterus precluded the continuation of the procedure. Insertion problems were encountered in 31 women (10.5%). Syncope occurred in 4 women and one of the women developed a 'grand mal' seizure. Clinically significant pelvic infection occurred within 30 days of insertion in 5 women (approximately 1% of insertions), and one woman developed pelvic infection from gonorrhoea.

Adolescent↗

Norplant consensus statement and background review.

This review has highlighted the attributes of a very important new method of contraception. The signatories to this document agree that, with the provision of appropriate information and instruction for the user, Norplant is a good contraceptive choice to be made available worldwide in family planning programs that have the resources for appropriate training and counseling. The signatories to this document are acting in their own personal capacity and not as representatives of any particular organization.

Contraceptive Agents, Female↗

Poly(DL-lactide-co-glycolide)/norethisterone microcapsules: an injectable biodegradable contraceptive.

Microcapsules made from a biocompatible, biodegradable polymeric excipient, poly(DL-lactide-co-glycolide) (DL-PLGA) that contained 22 weight percent (wt %) norethisterone (NET), were prepared by a solvent-evaporation microencapsulation process. The effects of changing both the lactide-to-glycolide ratio of the DL-PLGA and the size of the microcapsules on the rate of NET release and the rate of excipient biodegradation were determined in vivo. NET release rates were determined in baboons after injecting the microcapsule formulations intramuscularly. Serum samples obtained at various times following treatment were analyzed for NET, progesterone, and estrogen by radioimmunoassay (RIA). Biodegradation kinetics were determined by injecting NET microcapsules made from radiolabeled DL-PLGA intramuscularly into the hind legs of rats. Residual radioactivity at the injection site was determined at various times after treatment by combustion analysis of the muscle tissue. Changing the ratio of the comonomers to include more glycolide (DL-lactide:glycolide-96:4, 92:8, 87:13, 74:26) increased the rate of NET release and accelerated the biodegradation of the copolymer excipient. Decreasing the size of the microcapsules increased the rate of NET release. On the basis of these studies a NET microcapsule formulation has been identified for clinical testing which releases NET for 3 months and biodegrades completely within 6 months.

Animals↗

Effects of rifabutin and rifampicin on the pharmacokinetics of ethinylestradiol and norethindrone.

This open-label, randomized, three-way crossover study of 28 healthy premenopausal women was conducted to compare the impact of concomitant rifabutin and rifampicin on the safety, pharmacokinetics, and pharmacodynamics of the oral contraceptives ethinylestradiol and norethindrone (Ortho-Novum 1/35; Ortho Pharmaceutical, Raritan, NJ). Each participant received oral contraceptives daily for 21 days for the first control cycle, then was randomized to one of two sequences to receive oral contraceptives with concomitant rifampicin and rifabutin at equal doses of 300 mg/day for 10 days. Ethinylestradiol, norethindrone, follicle stimulating hormone (FSH), luteinizing hormone (LH), progesterone, rifampicin, and rifabutin (and metabolite) were measured in plasma over the same time frames in all three cycles. Safety was assessed from before the beginning to the end of each cycle. Twenty-two subjects completed all three cycles. Compared with the control cycle, rifabutin and rifampicin significantly altered the disposition of the oral contraceptive. Area under the concentration-time curve from 0 to 24 hours (AUC0-24) and maximum plasma concentration (Cmax) of ethinylestradiol decreased by 64% and 42%, respectively, after coadministration with rifampicin and by 35% and 20%, respectively, after coadministration with rifabutin. The AUC0-24 of norethindrone decreased by 60% and 20% after coadministration with rifampicin and rifabutin, respectively. Unlike progesterone levels, FSH and LH levels increased during coadministration with rifampicin and rifabutin. The incidence of spotting was significantly higher after coadministration with rifampicin (36.4%) and rifabutin (21.7%) than during the control cycle (3.7%). Although both rifampicin and rifabutin affected the pharmacokinetics of ethinylestradiol and norethindrone, the magnitude of this effect was more pronounced with rifampicin. Likewise, the fact that the highest incidence of spotting occurred with rifampicin was consistent with higher metabolic induction by rifampicin. Despite the fact that there was no change in progesterone levels, it is recommended that patients be advised to use additional contraceptive methods while receiving rifabutin or rifampicin with oral contraceptives to prevent inadvertent pregnancy.

Adolescent↗

Some adverse effects of copper-IUD.

Perforations and extraction problems in some 30 700 women wearing a copper intrauterine device (Cu-IUD), either a Cu-7 or Cu-T have been studied. Perforations were very rare. Judging from the literature and the present investigation, in cases of perforation the Cu-7-IUD has a tendency to penetrate the uterine wall and the Cu-T-IUD the cervical wall. Retracted and detached strings were observed somewhat more often in women wearing Cu-7-IUD's. The number of such cases was, however, not large enough to warrant a statistical comparison. The cause of retention, investigative procedures and recommendations in the removal of lodged Cu-IUD's are discussed.

Cervix Uteri↗

Three years of experience after post-abortal insertion of Nova-T and Copper-T-200.

The results of 3 years of follow-up of a randomized comparative study of 331 women who had an IUD inserted immediately after a first-trimester legal abortion are presented. In one group of women, 172 Nova-T were inserted and in another, 159 Copper-T 200. There was no statistically significant difference between the two groups, though the pregnancy rate for Nova-T was considerable lower than for Copper-T 200. The overall performance of the IUD equals that in a larger material of more than 1 800 insertions, both post menstrual and post abortal , of which this study is a part.

Abortion, Induced↗

Normoprolactinemic galactorrhea in a fertile woman with a copper intra-uterine device (copper IUD).

We report a case of galactorrhea in a normoprolactinemic fertile woman (30 years old) wearing a copper intra-uterine device (Gravigard). The Gravigard was first inserted in July 1977. In February 1979 our patient noted spontaneous galactorrhea, mainly on the left, but it was also present on the right, after breast pressure. X-ray film of the sella turcica, visual-field examination, thyroid function and basal prolactin levels were all within normal limits. In May 1979 the Gravigard was withdrawn and milk loss stopped finally in December 1979. In March 1980 the IUD was replaced; after only 3 days, mild spontaneous lactation again ensued, on the right side. The patient never took drugs which might have occasioned a prolactin rise. Possible explanations for this unusual phenomenon are discussed.

Adult↗

Contraceptive services for adolescents in Latin America: facts, problems and perspectives.

This review presents facts about sexual and contraceptive behavior of Latin American adolescents, analyzes barriers to contraception, and summarizes present perspectives. Between 13 and 30% of Latin American adolescent women live in union before their 20th birthday and between 46 and 63% have had sexual relations. The prevalence of contraceptive use among adolescents at risk of pregnancy remains very low. The pill is the best known contraceptive method. When sexual activity becomes a permanent practice, contraceptive use increases but remains low. Barriers to contraception can be identified as: (1) arising from adolescents themselves (moral objections, alleged medical reasons, lack of confidence in adults and in the health system, promiscuity; (2) arising from the sexual partner (partner's opposition, masculine irresponsibility); (3) arising from adults (moral objections, fear of sex education, adult control and power of decision-making); (4) arising from the health system (inappropriateness of services, regulatory barriers, gender inequality); (5) arising from health professionals (medical barriers to contraceptive use, discomfort with sexual matters); (6) arising from the educational system (educational failure, teachers' reluctance); and (7) arising from other social agents (religious opposition, media ambivalent messages, fund restraints). There have been improvements in recent years, including the achievements of groups working for and with adolescents, and the support from distinguished personalities.

Adolescent↗