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Scoping Review to Map Evidence on Mechanism of Action, Pharmacokinetics, Effectiveness and Side Effects of Centchroman As a Contraceptive Pill

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Scoping Review to Map Evidence on Mechanism of Action, Pharmacokinetics, Effectiveness and Side Effects of Centchroman As a Contraceptive Pill Open access Original research BMJ Open: first published as 10.1136/bmjopen-2019-030373 on 7 October 2019. Downloaded from Scoping review to map evidence on mechanism of action, pharmacokinetics, effectiveness and side effects of centchroman as a contraceptive pill Rita Kabra,1 Komal Preet Allagh ,2 Moazzam Ali ,1 Chandani Anoma Jayathilaka,3 Kasonde Mwinga,4 James Kiarie1 To cite: Kabra R, Allagh KP, ABSTRACT Strengths and limitations of this study Ali M, et al. Scoping review to Objective To systematically identify and map the available map evidence on mechanism evidence on effectiveness, side effects, pharmacokinetics ► Strength of our study is that it is the first scoping of action, pharmacokinetics, and mechanism of action of centchroman as a effectiveness and side review to explore the mechanism of action, phar- contraceptive pill. effects of centchroman as a macokinetics, effectiveness and side effects of Introduction Centchroman was introduced in the Indian contraceptive pill. BMJ Open centchroman, when used as a weekly or postcoital national family planning programme in 2016 as a once- 2019;9:e030373. doi:10.1136/ contraceptive pill. bmjopen-2019-030373 a-week short-term contraceptive pill/oral contraceptive. ► A limitation of our review is that we are likely to have At present there are no WHO recommendations on this missed studies on mechanism of action of centchro- ► Prepublication history for method of contraception. We examined the available this paper is available online. man since animal studies were excluded from the evidence through a scoping review. To view these files, please visit review. Methods A search was conducted inclusive to the years the journal online (http:// dx. doi. ► All identified studies in this scoping review were 1970–2019 on electronic databases, grey literature org/ 10. 1136/ bmjopen- 2019- from India. Additionally, roughly half of the studies sources and reference lists of included studies to identify 030373). in this review were published from the developers of studies. The five stages of Arksey and O’Malley’s scoping the drug (Central Drug Research Institute). Received 11 March 2019 review framework were applied in undertaking this ► There is no detailed drug trial on use of centchroman Revised 27 August 2019 scoping review. as a postcoital contraceptive pill. Accepted 02 September 2019 Results The review identified 33 studies conducted ► Studies on side effects of centchroman as a contra- http://bmjopen.bmj.com/ between 1976 and 2017. Two studies reported mechanism ceptive pill are limited by small sample size, short of action of centchroman. Pharmacokinetics was reported duration of follow-up and the fact that all studies by five studies among non-breastfeeding women and have been conducted in India. four studies among breastfeeding women. Eight studies reported on effectiveness ranging from 93% to 100%. Pregnancies due to user failure ranged from 2.6% © Author(s) (or their 1 to 10.2%. Although side effects were reported in 13 oestrogenic or antiestrogenic effects. It employer(s)) 2019. Re-use suppresses the oestrogen receptors in the permitted under CC BY-NC. No studies, the incidence varied greatly between the studies. Continuous bleeding and prolonged cycles >45 days were reproductive organs, but stimulates those commercial re-use. See rights 1 2 on September 27, 2021 by guest. Protected copyright. and permissions. Published by the most commonly reported side effects. All studies of other organs like the bones. It is used BMJ. conducted had a small sample size and the duration of as a contraceptive pill/oral contraceptive 1Department of Reproductive follow-up of women was 12 months or less. Fifty-five per and in treatment of dysfunctional uterine Health and Research, World cent of studies were by the developers of the pill (Central bleeding, mastalgia and fibroadenoma due Health Organization, Geneva, Drug Research Institute) and results of the phase IV clinical to its oestrogen antagonist effect.3 Due to Switzerland trial were unavailable. 2Consultant, World Health its oestrogen agonist effect, centchroman is Conclusions The scoping review shows that studies with used for management of osteoporosis and Organization, Geneva, robust designs and conducted in international context Switzerland its levoisomer has been shown to have some are lacking. Insufficient evidence exists on centchroman 3Department of Family Health, 3 use as a postcoital contraceptive pill. The broad cardioprotective effects. The reported advan- Gender and Life course, World tages of centchroman over other contracep- Health Organization Regional uncertainty in range of side effects and effectiveness in Office for South-East Asia, New the studies implies insufficient evidence to make global tive pill/oral contraceptives are: (1) it is taken Delhi, India recommendations on centchroman that is currently once a week; (2) it does not have any side 4World Health Organization licensed as a contraceptive in India. effects seen with hormonal pills like nausea, Country Office for India, New vomiting and weight gain; (3) it is considered Delhi, India safe for use among breastfeeding women4; Correspondence to INTRODUCTION and (4) it can be taken by women of all ages. Dr Komal Preet Allagh; Centchroman acts as a selective oestrogen In the 1960s, the Government of India called komal. allagh@ gmail. com receptor modulator with tissue selective on Indian laboratories to develop alternate Kabra R, et al. BMJ Open 2019;9:e030373. doi:10.1136/bmjopen-2019-030373 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-030373 on 7 October 2019. Downloaded from birth control pills. The team at Central Drug Research In this review we have focused on the use of centchroman Institute (CDRI) took up this challenge and synthesised3 5 as an contraceptive pill/oral contraceptive (weekly pill centchroman (3,4-trans-2,2-dimethyl-3-phenyl-4-p(β-pyr- and postcoital pill). As a weekly contraceptive pill, the rolidinoethoxy)-phenyl-7-methoxychroman) in recommended dosage of centchroman is a 30 mg pill 1967.3 6 Since it was made at CDRI and belongs to the twice a week for 12 weeks, followed by a 30 mg pill once chroman family, it was named as centchroman. In 1994, a week.4 5 Centchroman as an emergency postcoital pill centchroman was given an international non-proprietary is taken as a 60 mg dose within 72 hours of intercourse.12 7 name as ormeloxifene. Following preclinical and clin- We are conducting this scoping review to determine the ical studies (phase 1 and 2) in 1989 the Drug Controller scope/coverage of the body of literature on effectiveness, General of India approved centchroman as a contracep- safety, pharmacokinetics and mechanism of action of 3 6 tive pill/oral contraceptive in 1991. It was available in centchroman as a contraceptive pill (weekly and postco- the Indian market since 1992. It was first manufactured ital). This review will identify and map the types of avail- by Torrent Pharmaceuticals, Ahmedabad, and marketed able evidence on centchroman as a contraceptive pill and under brand name Centron. Later, Hindustan Latex determine any knowledge gaps. Limited (HLL) Lifecare, Thiruvananthapuram, manu- factured it under the brand names Choice-7 and Saheli.8 Aims and objectives The Ministry of Health and Family Welfare, India, has This scoping review aims to systematically include the distributed centchroman at a subsidised cost since 1995 3 6 entire range of published and grey literature on: (social marketing scheme). ► Extent and type of evidence on effectiveness and side In 2008, HLL Lifecare entered the international market by launching centchroman as a postcoital pill under the effects of using centchroman as a contraceptive pill brand name Ivyfemme in Peru, South America.9 However, (weekly and postcoital pill). in 2010 the licence to sell the pill was revoked by Peru’s ► Extent of evidence on mechanism of action of Directorate General of supplies and drugs. The reason centchroman when used as a contraceptive in women. given for this was that the pill acted by preventing implan- ► Extent of evidence on pharmacokinetics of tation of a fertilised egg and sale of any abortifacient drug centchroman among both non-lactating and breast- was considered illegal in Peru.9 In 2013, HLL Lifecare feeding women. launched centchroman as a postcoital pill in India under METHODS the brand name Tatkal-72.10 The production of Tatkal-72 A protocol for this scoping review was developed a priori was discontinued in 2014 due to restrictions on marketing using the Arksey and O’Malley York’s five-stage frame- and advertising of emergency contraceptive pills in India. work.13 The five steps of the scoping review were: (1) The Ministry of Health and Family Welfare, India, in April 2016 decided to expand oral contraceptive options identifying the research question; (2) identifying the http://bmjopen.bmj.com/ by including centchroman in the national family plan- search strategy; (3) study selection; (4) data charting; and ning programme under the brand name Chhaya.4 5 11 (5) collating, summarising and reporting the results. Chhaya is available to women through the public delivery system free of cost. Oral contraceptives that are safe Step 1: identification of the research question among breastfeeding women have a better potential to This scoping review was conducted to answer the improve the use of family planning methods by post- following primary research question: What is the current partum women, hence centchroman was included in the state of evidence on effectiveness and side effects of centchroman national family planning programme. Figure 1 depicts as a contraceptive pill (weekly pill and postcoital pill)? The on September 27, 2021 by guest. Protected copyright. the key milestones in the evolution of centchroman in secondary research questions were: What is current avail- India. able evidence on mechanism of action of centchroman in women? Figure 1 Key milestones on evolution of centchroman. CDRI, Central Drug Research Institute.
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