These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Phase III clinical trial with Norplant II (two covered rods): report on five years of use.
    Journal: Contraception; 1993 Aug; 48(2):120-32. PubMed ID: 8403909.
    Abstract:
    The subdermal implant NORPLANT II contraceptive was studied for its safety, efficacy and acceptability over a period of 5 years of use in a phase III multicentre clinical trial. A total of 1,466 women were observed for 52,849 women-months of use. Only four pregnancies were reported during the study period, giving a method failure rate of 0.8 per 100 users at 5 years of use. The continuation rates were 61.4, 49.0 and 42.1 per 100 users at 3, 4 and 5 years of use, respectively. The majority of the discontinuations were due to bleeding irregularities which accounted for 22.2, 26.3 and 28.5 per 100 users at 3, 4 and 5 years of use, respectively. The next common reason was planning pregnancy which was observed mainly in women having one child. The discontinuations due to infection, expulsion or displacement of device were very low (0.2-0.3 per 100 users). Due to vigorous efforts made by the centers to follow the subjects, the lost-to-follow-up rate was very low (1.6% at 5 yr). At 15 Human Reproduction Research Centres in India, clinicians inserted the 2 sterile rods of the Norplant II system (80 mcg levonorgestrel released/24 hours for first 6-18 months, 30 mcg levonorgestrel/24 hours thereafter) in the left arm of 1466 women, 18038 years old and conducted follow-up visits at 7 days and at 1, 3, and 6 months; and every 6 months thereafter for 5 years for a total of 52,849 women-months of use to determine Norplant II's safety, efficacy, and acceptability. Just 4 pregnancies occurred over 5 years (pregnancy rate = 0.8%). 1 woman became pregnant while taking Rifampicin and, like 2 other pregnant women, underwent induced abortion. Just 1 woman continued the pregnancy. Continuation rates stood at 61.4, 49, and 4.21% at 3, 4, and 5 years of use, respectively. The 5-year lost to follow-up rate was just 1.6%. Menstrual irregularities, e.g., prolonged or excessive bleeding, accounted for most discontinuations (22.2, 26.3, and 28.5% at 3, 4, and 5 years of use, respectively). The next most frequent reason for discontinuation was desire for another child, specially among mothers of 1 child and 3 years of use. A positive association existed between number of living children and continuation rates (e.g., at 5 years, 30.9% for 1 child vs. 51.7% for = or 3 children; p .001). The implant was displaced from the original site of insertion in 85 women (5.8%), but the displacements did not require removal, except in 2 women where the implant migrated to the elbow crease. Clinicians reported difficulty in removal of implants in 55 women (3.8%) due to broke rods(s) and migration along the tract or to deeper layers. Norplant II increased the mean weight significantly (44.6 kg at enrollment vs. 46 kg, 46.7 kg, 47.5 kg, 47.6 kg, and 49 kg at 1, 2, 3, 4, and 5 years, respectively; p .001). The US Environmental Protection Agency required the manufacturer of Medical Grade Elastomer 382 to conduct additional testing in animals because an ingredient in the elastomer caused liver tumors in rats and mice at high doses. This action has prevented the widespread availability of Norplant II.
    [Abstract] [Full Text] [Related] [New Search]