Ormeloxifene Explained

Bc Type:Antiestrogen
Date First Use:1991
Rate Type:Failure
Perfect Failure%:2
Typical Failure%:9
Duration Effect:One week
Reversibility:Immediate
User Reminders:Taken twice weekly for first 13 weeks
Clinic Interval:Annually
Std Protection Yesno:No
Benefits:Non hormonal
Breastfeeding Yesno:Yes[1]
Periods:May disrupt
Weight Gain Loss:No proven effect
Risks:Delayed menstruation
Medical Notes:Only approved as a contraceptive in India

Ormeloxifene, also known as centchroman, is one of the selective estrogen receptor modulators,[2] or SERMs, a class of medication which acts on the estrogen receptor. It is best known as a nonsteroidal oral contraceptive which is taken once per week. In India, ormeloxifene has been available as birth control since the early 1990s, and it was marketed there under the trade name Saheli,[3] currently available free-of-cost for the women in India as Chhaya (Centchroman).[4] [5]

Ormeloxifene has also been licensed under the trade names Ormalin, Novex-DS, Centron, and Sevista.

Medical uses

Ormeloxifene is primarily used as a contraceptive but may also be effective for dysfunctional uterine bleeding and advanced breast cancer.[6]

Birth control

Ormeloxifene may be used as a weekly oral contraceptive.[6] The weekly schedule is an advantage for women who prefer an oral contraceptive, but find it difficult or impractical to adhere to a daily schedule required by other oral contraceptives.

For the first twelve weeks of use, it is advised to take the ormeloxifene pill twice per week.[6] From the thirteenth week on, it is taken once per week.[6] [7] The consensus is that backup protection in the first month is a cautious but sensible choice. A standard dose is 30 mg weekly, but 60 mg loading doses can reduce pregnancy rates by 38%.[8]

It has a failure rate of about 1-2% with ideal use which is slightly less effective than found for combined oral contraceptive pills.

Other indications

Side effects

There are concerns that ormeloxifene may cause delayed menstruation.[11]

Pharmacology

Ormeloxifene is a selective estrogen receptor modulator (SERM). In some parts of the body, its action is estrogenic (e.g., bones), in other parts of the body, its action is antiestrogenic (e.g., uterus, breasts).[12] [13] [14] It causes an asynchrony in the menstrual cycle between ovulation and the development of the uterine lining, although its exact mode of action is not well defined. In clinical trials, it caused ovulation to occur later than it normally would in some women, but did not affect ovulation in the majority of women, while causing the lining of the uterus to build more slowly. It speeds the transport of any fertilized egg through the fallopian tubes more quickly than is normal. Presumably, this combination of effects creates an environment such that if fertilization occurs, implantation will not be possible.[15]

History

Ormeloxifene was first discovered by Central Drug Research Institute (CDRI) in Lucknow, India.[16] Ormeloxifene was marketed in Delhi in July 1991 and in India in 1992, under the brand names Saheli and Choice-7.[17]

Since 2018, Centchroman is provided free-of-cost to the women in India by the government under the brand name Chhaya.[18] [19] [20]

Society and culture

Marketing

As of 2009, ormeloxifene was legally available only in India.[21]

Ormeloxifene has been tested and licensed as a form of birth control, as well as a treatment for dysfunctional uterine bleeding.

See also

Further reading

External links

Notes and References

  1. Gupta RC, Paliwal JK, Nityanand S, Asthana OP, Lal J . Centchroman: a new non-steroidal oral contraceptive in human milk . Contraception . 52 . 5 . 301–305 . November 1995 . 8585887 . 10.1016/0010-7824(95)00214-U .
  2. Makker A, Tandon I, Goel MM, Singh M, Singh MM . Effect of ormeloxifene, a selective estrogen receptor modulator, on biomarkers of endometrial receptivity and pinopode development and its relation to fertility and infertility in Indian subjects . Fertility and Sterility . 91 . 6 . 2298–2307 . June 2009 . 18675966 . 10.1016/j.fertnstert.2008.04.018 . free .
  3. Web site: HLL - Product Overview . https://web.archive.org/web/20181101091837/http://www.hindlatex.com/TipsnGuidesdetails.aspx?valid=1&category=0&id=170&type=25 . 1 November 2018 . dead .
  4. Web site: Chhaya . 2020-06-29 . Centre for Health Informatics (CHI) of the National Health Portal (NHP), by the Ministry of Health and Family Welfare (MoHFW) . Government of India . 11 May 2021. https://web.archive.org/web/20210511165301/https://humdo.nhp.gov.in/choice_for_planning/chhaya/ . dead.
  5. Web site: 2018-07-10. Contraception and women's empowerment: Here's how safe, reliable contraceptives are freeing women to earn. 2020-06-29. Hindustan Times. en.
  6. Lal J . Clinical pharmacokinetics and interaction of centchroman--a mini review . Contraception . 81 . 4 . 275–280 . April 2010 . 20227542 . 10.1016/j.contraception.2009.11.007 .
  7. Web site: Home | ReproLinePlus .
  8. Lal J, Nitynand S, Asthana OP, Nagaraja NV, Gupta RC . Optimization of contraceptive dosage regimen of Centchroman . Contraception . 63 . 1 . 47–51 . January 2001 . 11257249 . 10.1016/S0010-7824(00)00189-X .
  9. Kriplani A, Kulshrestha V, Agarwal N . Efficacy and safety of ormeloxifene in management of menorrhagia: a pilot study . The Journal of Obstetrics and Gynaecology Research . 35 . 4 . 746–752 . August 2009 . 19751337 . 10.1111/j.1447-0756.2008.00987.x . 39172838 .
  10. Dhar A, Srivastava A . Role of centchroman in regression of mastalgia and fibroadenoma . World Journal of Surgery . 31 . 6 . 1178–1184 . June 2007 . 17431715 . 10.1007/s00268-007-9040-4 . 22828570 .
  11. Shelly W, Draper MW, Krishnan V, Wong M, Jaffe RB . Selective estrogen receptor modulators: an update on recent clinical findings . Obstetrical & Gynecological Survey . 63 . 3 . 163–181 . March 2008 . 18279543 . 10.1097/OGX.0b013e31816400d7 . 23585991 .
  12. Web site: CSIR-CDRI Home. 2020-06-29. cdri.res.in.
  13. Kumar GR, Rituraj K, Hemant BK, Singh MM . In-vitro anti-cancer breast activity of ormeloxifene is mediated via induction of apoptosis and autophagy. . 37th annual conference of the endocrine society of India . November 2007 . 30 . 35 .
  14. Nigam M, Ranjan V, Srivastava S, Sharma R, Balapure AK . Centchroman induces G0/G1 arrest and caspase-dependent apoptosis involving mitochondrial membrane depolarization in MCF-7 and MDA MB-231 human breast cancer cells . Life Sciences . 82 . 11–12 . 577–590 . March 2008 . 18279897 . 10.1016/j.lfs.2007.11.028 .
  15. Singh MM . Centchroman, a selective estrogen receptor modulator, as a contraceptive and for the management of hormone-related clinical disorders . Medicinal Research Reviews . 21 . 4 . 302–347 . July 2001 . 11410933 . 10.1002/med.1011 . 37474826 .
  16. Web site: Centchroman . CSIR-CDRI . 25 September 2018 . https://web.archive.org/web/20190214191222/http://www.cdri.res.in/Centchroman.aspx . 14 February 2019 . dead .
  17. Lal J . Clinical pharmacokinetics and interaction of centchroman--a mini review . Contraception . 81 . 4 . 275–280 . April 2010 . 20227542 . 10.1016/j.contraception.2009.11.007 .
  18. Web site: 22 May 2018 . परिवार नियोजन विधियों में छाया से अधिक अंतरा में बढ़ी महिलाओं की दिलचस्पी, जानिये इनके बारे में . 2020-06-29 . Patrika News . hindi.
  19. Web site: 7 April 2018 . antara chhaya: Two months after launch, Antara, Chhaya contraceptives get good response from locals . 2020-06-29 . The Times of India . en . Bhatia I.
  20. News: 2018-01-12 . BMC rolls out new contraceptive pill . en-IN . The Hindu . 2020-06-29 . 0971-751X . Shelar J.
  21. Book: Tribhuwan RD, Patil BD . Body image : human reproduction and birth control : a tribal perspective. 2009. Discovery Pub. House. New Delhi. 978-81-8356-388-8. 20.

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