Phase II randomized comparative clinical trial of Norplant (six capsules) with Norplant-2 (two covered rods) subdermal implants for long-term contraception: report of a 24-month study. National Programme of Research in Human Reproduction.
In a randomized clinical study, contraceptive efficacy and bleeding patterns were studied in a group of healthy, regularly menstruating, non-lactating women (n = 84) using two 4.4 cm covered silastic rods containing levonorgestrel, Norplant(R)-2, and compared with another group of women (n = 88) using six 3.4 cm capsules also containing levonorgestrel, Norplant(R). The silastic rods or capsules were placed subdermally in the medial aspect of the upper arm. No method failure was reported up to 24 months of use in this study with either of the device. The bleeding pattern was also similar for both devices as indicated by average episode length, number of bleeding runs and number of spotting days. The continuation rates with both devices were over 80 per 100 users at the end of 12 months and over 65 per 100 users at the end of 24 months. Discontinuations due to expulsion of the device, bleeding problems or personal reasons were few and similar for both devices. The results suggest that silastic-covered rods, Norplant(R)-2, which are comparatively easier to insert and remove and have similar clinical effect, could replace capsules, Norplant(R), as a long-term reversible subdermal contraceptive.
D000293:Adolescent; D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced; D002986:Clinical Trials as Topic; D004343:Drug Implants; D005260:Female; D006801:Humans; D016912:Levonorgestrel; D008599:Menstruation Disturbances / Q000139:chemically induced; D009644:Norgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D009839:Oligomenorrhea / Q000139:chemically induced; D011897:Random Allocation; D013997:Time Factors
D004343:Drug Implants; D009644:Norgestrel; D016912:Levonorgestrel