Phase II--clinical trial with biodegradable subdermal contraceptive implant Capronor (4.0-cm single implant). Indian Council of Medical Research Task Force on Hormonal Contraception.
The subdermal biodegradable contraceptive implant Capronor (4.0 cm) was implanted in 41 women to observe the efficacy and side effects. Only one pregnancy was reported at 10 months of use, and the life table continuation rate at 12 months was 82.2 per 100 users. No serious clinical side effects were reported during the study period. The menstrual pattern was disrupted during the first 3 months of implant use in two-thirds of the women which improved by the end of 12 months of use. The results of this Phase II study suggest that Capronor is a safe and effective long-acting contraceptive. These findings need to be confirmed in a Phase III clinical trial on a larger sample size.
D000293:Adolescent; D000328:Adult; D000568:Amenorrhea / Q000209:etiology; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards; D004341:Drug Evaluation; D004343:Drug Implants; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D016912:Levonorgestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards*; D015993:Life Tables
D003271:Contraceptive Agents, Female; D004343:Drug Implants; D016912:Levonorgestrel