Scoping review to map evidence on mechanism of action, pharmacokinetics, effectiveness and side effects of centchroman as a contraceptive pill

• Published in: BMJ open Vol. 9; no. 10; p. e030373
• Main Authors: Kabra, Rita, Allagh, Komal Preet, Ali, Moazzam, Jayathilaka, Chandani Anoma, Mwinga, Kasonde, Kiarie, James
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01-10-2019; BMJ Publishing Group
• Subjects: Birth control; Brand names; Breastfeeding & lactation; Centchroman - pharmacology; Childrens health; Contraceptives, Oral - pharmacology; Contraceptives, Oral - standards; Drug dosages; Estrogen Antagonists - pharmacology; Family planning; Female; Humans; Marketing; Maternal & child health; Medical research; Pharmacokinetics; Pharmacovigilance; Product Surveillance, Postmarketing - statistics & numerical data; Reproductive health; Reproductive Medicine; Research centers; Side effects; Systematic review; Treatment Outcome; Womens health; Peru; India; effectiveness; oral pill; Ormeloxifene; contraception; safety; Centchroman
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2019-030373

ObjectiveTo systematically identify and map the available evidence on effectiveness, side effects, pharmacokinetics and mechanism of action of centchroman as a contraceptive pill.IntroductionCentchroman was introduced in the Indian national family planning programme in 2016 as a once-a-week short-term contraceptive pill/oral contraceptive. At present there are no WHO recommendations on this method of contraception. We examined the available evidence through a scoping review.MethodsA search was conducted inclusive to the years 1970–2019 on electronic databases, grey literature sources and reference lists of included studies to identify studies. The five stages of Arksey and O’Malley’s scoping review framework were applied in undertaking this scoping review.ResultsThe review identified 33 studies conducted between 1976 and 2017. Two studies reported mechanism of action of centchroman. Pharmacokinetics was reported by five studies among non-breastfeeding women and four studies among breastfeeding women. Eight studies reported on effectiveness ranging from 93% to 100%. Pregnancies due to user failure ranged from 2.6% to 10.2%. Although side effects were reported in 13 studies, the incidence varied greatly between the studies. Continuous bleeding and prolonged cycles >45 days were the most commonly reported side effects. All studies conducted had a small sample size and the duration of follow-up of women was 12 months or less. Fifty-five per cent of studies were by the developers of the pill (Central Drug Research Institute) and results of the phase IV clinical trial were unavailable.ConclusionsThe scoping review shows that studies with robust designs and conducted in international context are lacking. Insufficient evidence exists on centchroman use as a postcoital contraceptive pill. The broad uncertainty in range of side effects and effectiveness in the studies implies insufficient evidence to make global recommendations on centchroman that is currently licensed as a contraceptive in India.