A postmarketing observational study assessing acceptability and reliability of desogestrel only contrapceptive pill (Cerazette) in Indian women.
A postmarketing observational study was carried out in a prospective, open and multi-centric manner monitoring a treatment period of 4 cycles (4 x 28 days) among Indian women of child bearing age to determine the acceptability and reliability of desogestrel (75 microg/day), an oestrogen-free pill. It involved 299 subjects recruited at each of 20 centres spread all over India. The study duration for each subject was 16 weeks with follow-up visits at 4, 8 and 16 weeks intervals. At each follow-up visit, subjects were evaluated for any failure of contraception, change in bleeding pattern and other adverse events. Of the study subjects, 238 (79.6%) continued the study for 4 cycles and were thus considered eligible for analysis of bleeding patterns with no failure of contraception. In addition, the physician's as well as patient's global assessment, demonstrated a "very good" response in majority of subjects (> 84%). A sizeable number of cases (47.9%) had infrequent episodes (1 to 5) of bleeding--spotting during the shifted reference period, while 41.2% experienced amenorrhoea. There was no clinically significant change in blood pressure or body weight. Of the 299 such subjects enrolled, 53 subjects were lost to follow-up and did not come for the 1st follow-up visit. Hence, out of the 246 subjects, 21.1% presented with 78 separate adverse events during 960 treatment cycles. None of the reported adverse events were severe and there was not even a single serious adverse effect during the course of the study. Nausea, breast tenderness and headache (7.7%, 10.1% and 9.7% respectively) were the most frequent adverse events observed during the study. Desogestrel 75 mg/day was well accepted in majority of Indian women. It provides good contraceptive efficacy, with a lower incidence of irregular bleeding and spotting episodes.
Ray
Subrat
S
Medical Department, Organon (India) Limited, Mumbai.
Sovani
Vishwas B
VB
D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007194:India; D010342:Patient Acceptance of Health Care; D011358:Product Surveillance, Postmarketing
D003271:Contraceptive Agents, Female; D003280:Contraceptives, Oral, Synthetic; D017135:Desogestrel