Ormeloxifene

Pronunciation: or-mel-OX-i-feen.

Generic name
ormeloxifene (centchroman)
Drug class
Selective estrogen receptor modulator (SERM) -- non-hormonal, non-steroidal oral contraceptive / uterine-bleeding agent
Form
Tablet, 30 mg
Route
Oral
Legal status
Authorised and marketed only in India, where it is approved by India's national drug regulatory authority and distributed both commercially (as Saheli) and free of cost through the government's National Family Planning Programme (as Chhaya). No evidence of authorisation was found in the United States, United Kingdom, European Union, Canada, Australia, or New Zealand -- confirmed as a clean, live zero-result search in the United States (DailyMed), United Kingdom (electronic Medicines Compendium), and Australia (TGA); the European Union, Canada, and New Zealand live database queries returned technical errors this session rather than a clean result, so those three are honestly recorded as unable to verify rather than assumed absent.

Availability and supply rules vary by country

Trade names by country: India

Australia: · Full directory

What ormeloxifene (centchroman) is and how it works

Ormeloxifene (centchroman) is a non-hormonal, non-steroidal selective estrogen receptor modulator (SERM) developed in India and used mainly as a once-weekly oral contraceptive. Unlike hormonal birth control pills, it does not contain estrogen or progestin; instead, it acts against estrogen's effects in the uterus (preventing the womb lining from supporting implantation of a fertilised egg) while behaving mildly like estrogen in bone. It does not stop ovulation or disrupt the body's normal hormonal cycle. It is also used to treat dysfunctional (abnormal) uterine bleeding. (2) (1)

Ormeloxifene is only authorised and marketed in India -- no evidence was found of it being an approved medicine in the United States, United Kingdom, European Union, Canada, Australia, or New Zealand. In India it is available both commercially (as Saheli) and free of cost through government health centres (as Chhaya) as part of the national family planning programme. Because it is non-hormonal, it avoids many of the metabolic side effects (on blood sugar, cholesterol, blood pressure, and blood clotting) associated with hormonal contraceptives, and is generally considered compatible with breastfeeding. Real-world Indian clinical data shows it is generally well tolerated, with the most common issue being a delayed or irregular period.

Mechanism of action: how ormeloxifene (centchroman) works

Ormeloxifene is a selective estrogen receptor modulator (SERM), acting as an estrogen-receptor antagonist in the uterus/endometrium and breast tissue while behaving as a weak estrogen agonist in bone. Its main contraceptive mechanism is inhibition of blastocyst implantation via effects on endometrial receptivity, without suppression of ovulation or disruption of the hypothalamic-pituitary-ovarian axis. (2) (1)

What ormeloxifene (centchroman) is used for

Contraception (once-weekly oral contraceptive)

Used in India as a non-hormonal, once-weekly oral contraceptive pill, taken by women wanting a hormone-free alternative to combined or progestin-only birth control pills. It prevents pregnancy mainly by preventing embryo implantation, without stopping ovulation. (1) (2)

Dysfunctional (abnormal) uterine bleeding

Also used under clinician direction in India to help manage dysfunctional uterine bleeding (heavy or irregular bleeding not caused by a structural problem), as part of the range of documented clinical uses for this medicine in Indian gynaecological practice. (3)

Before taking ormeloxifene (centchroman)

Do not take / not appropriate for

  • Do not take ormeloxifene if you are pregnant, or if you have a known hypersensitivity to it. (India) (3)
  • This product is not authorised outside India. It should not be assumed available, legal to import, or regulator-reviewed in the United States, United Kingdom, European Union, Canada, Australia, or New Zealand. (all countries outside India) (4) (5) (6)

Tell your clinician about

  • Any history of jaundice, liver disease, or kidney disease -- the sources reviewed for this dossier note limited formal renal/hepatic safety data, and this study's own exclusion criteria excluded women with chronic liver or kidney disease.
  • Any history of polycystic ovarian disease, chronic infections such as tuberculosis, hepatitis B or C, or cancer -- these were exclusion criteria in the clinical study reviewed for this dossier.
  • Whether you are over 40 years of age -- this was also an exclusion criterion in the clinical study reviewed.
  • Whether you are breastfeeding, planning pregnancy, or could already be pregnant.
  • All other medicines you take, so your clinician can check for possible interactions (no formally documented drug-drug interaction data was identified in the sources reviewed for this dossier).
(2) (3)

How to take ormeloxifene (centchroman)

  • The approved contraceptive regimen is a loading phase followed by a maintenance phase: two tablets per week (for example, on fixed days such as Sunday and Wednesday) for the first 12 weeks, then one tablet once a week from the fourth month onward, for as long as contraception is wanted.
  • Additional barrier contraception (such as condoms) is generally advised during the first 8 weeks while the loading phase takes effect.
  • May be taken with or without food.
  • Take on the same day(s) each week to help remember the once-weekly schedule; some Indian clinical programmes report patients using reminder alarms or SMS reminders to support adherence.
  • Do not change the dosing schedule on your own -- follow the schedule given by your clinician or the national family-planning-programme counselling you received.
(3) (1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Missing a weekly dose can raise the risk of contraceptive failure -- contact your clinician or the family-planning counsellor who provided your supply for specific guidance if you miss or are late taking a dose, and consider back-up contraception (such as condoms) until you are confident the schedule is back on track.

Overdose

Contact a doctor, pharmacist, or local poison-control service promptly for advice if a much larger amount than the recommended weekly dose has been taken, or if concerning symptoms develop. (3)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Delayed or irregular menstrual periods -- the most commonly reported effect (around 8-11% of users in the sources reviewed), usually settling with continued use.

What to notice: Delayed or irregular menstrual periods -- the most commonly reported effect (around 8-11% of users in the sources reviewed), usually settling with continued use.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2) (1)

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Abdominal discomfort.

What to notice: Abdominal discomfort.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Breast tenderness.

What to notice: Breast tenderness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Weight gain (uncommon in the real-world data reviewed).

What to notice: Weight gain (uncommon in the real-world data reviewed).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of pregnancy while taking ormeloxifene — high caution

Symptoms: Missed period beyond the usual delayed-menses pattern, or a positive pregnancy test.

Action: Contact your clinician immediately if pregnancy is confirmed or suspected, so they can advise you on stopping ormeloxifene and on next steps. The sources reviewed for this dossier report no fetal abnormalities in cases of method failure, but prompt clinician follow-up is still advised. (3)

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.

Action: Seek emergency medical help immediately. (3)

Interactions

  • No formally documented drug-drug interaction data was identified in the sources reviewed for this dossier -- disclose all other medicines to a clinician or pharmacist before combined use, especially given limited published interaction data. (3)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Not for use in pregnancy. Contact your clinician immediately if pregnancy is confirmed or suspected so they can advise on stopping ormeloxifene. The sources reviewed report no fetal abnormalities have been observed in cases of contraceptive failure, but this is not a substitute for clinician follow-up. (1) (2) (3) (4) (5) (6)

Breastfeeding

Considered compatible with breastfeeding per the sources reviewed -- human data cited suggests the drug does not pass into breast milk in significant amounts, and it is specifically positioned in Indian clinical practice as a safe option for breastfeeding women. Discuss with your clinician before use while breastfeeding. (1) (2) (3) (4) (5) (6)

Children

Not applicable -- this is an adult contraceptive/gynaecological medicine. (1) (2) (3) (4) (5) (6)

Elderly

No specific guidance identified in the sources reviewed; this study's population excluded women over 40 years of age. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Excluded from the real-world clinical study reviewed were women with chronic liver disease, recent jaundice, or hepatitis B/C infection; the sources reviewed disclose that renal and hepatic safety data are limited, so use in significant liver disease should be clinician-directed. (1) (2) (3) (4) (5) (6)

Renal_impairment

Excluded from the real-world clinical study reviewed were women with chronic kidney disease; the sources reviewed disclose that renal safety data are limited, so use in significant kidney disease should be clinician-directed. (1) (2) (3) (4) (5) (6)

Source_ids

IN-AIIMS-CUREUS-2026-CLINICAL-STUDY,IN-1MG-CENTCHROMAN-DOSING-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Confirm you are not currently pregnant
  • Discuss personal/family history of liver disease, kidney disease, polycystic ovarian disease, chronic infections (e.g. tuberculosis, hepatitis B/C), or cancer with your clinician
  • Receive counselling on the twice-weekly-then-weekly dosing schedule, as understanding the schedule is linked to better adherence

During treatment

  • Track your weekly dosing day(s) -- reminder alarms or SMS-based reminders have been used successfully in Indian family-planning programmes to support adherence.
  • Report any missed or delayed periods, new or worsening headache, breast tenderness, or abdominal discomfort to your clinician, and seek prompt medical advice for any signs of pregnancy.
(2)

Storage

Store tablets at room temperature, protected from light and moisture, out of reach of children, per standard Indian pharmacy storage practice for this product class.

Professional information

Clinician-facing context only. Ormeloxifene is authorised and reviewed only by India's national drug regulatory authority, so there is no FDA/EMA/MHRA-style prescribing information in the conventional sense. This section reflects the Indian government research-body account and peer-reviewed Indian clinical-study material reviewed for this dossier.

India

Indication: Contraception (once-weekly, non-hormonal); dysfunctional uterine bleeding

Dose summary: 30 mg tablet: twice weekly for the first 12 weeks (loading phase), then once weekly thereafter (maintenance phase). Pearl Index (contraceptive failure rate) reported at 0.2-2.0 per 100 woman-years across sources reviewed, with a 2026 real-world Indian cohort reporting 0.42 per 100 woman-years.

Renal context: No specific renal-dosing guidance identified in the sources reviewed; disclosed as limited. (3) (2)

United States / United Kingdom / European Union / Canada / Australia / New Zealand

Indication: Not applicable -- no evidence of authorisation found in any of these 6 markets.

Dose summary: Not applicable.

Renal context: Not applicable. (4) (5) (6)

Mechanism of action

Hepatic guidance

The sources reviewed disclose limited formal hepatic safety data; the real-world clinical study reviewed excluded women with chronic liver disease, recent jaundice, or hepatitis B/C.

Overdose note

No specific antidote identified in the sources reviewed; manage suspected significant overdose with supportive care and clinician or poison-control advice. (2) (1)

Frequently asked questions

Is ormeloxifene available or approved outside India?

No evidence of authorisation was found in the United States, United Kingdom, European Union, Canada, Australia, or New Zealand. Live database searches confirmed a clean zero result in the United States (DailyMed), United Kingdom (electronic Medicines Compendium), and Australia (TGA). For the European Union, Canada, and New Zealand, this session's live regulator-database queries returned technical errors rather than a clean result, so those three are honestly recorded as unable to verify rather than assumed to be either authorised or unauthorised. Ormeloxifene is genuinely authorised and marketed only in India, where it is used as a once-weekly, non-hormonal oral contraceptive (brands Saheli and Chhaya). (4) (5) (6) (7) (8) (9)

How is ormeloxifene different from hormonal birth control pills?

Ormeloxifene is non-hormonal and non-steroidal -- it does not contain estrogen or progestin. It works mainly by preventing a fertilised egg from implanting in the uterus, without stopping ovulation or disrupting the body's normal hormonal cycle. Because of this, real-world data reviewed for this dossier suggests it avoids many of the metabolic side effects (on blood sugar, cholesterol, blood pressure, and clotting factors) associated with hormonal contraceptives, and it is taken only once a week rather than daily. (2)

Is ormeloxifene safe while breastfeeding?

The sources reviewed for this dossier describe ormeloxifene as compatible with breastfeeding, with human data suggesting it does not transfer into breast milk in significant amounts, and it is specifically positioned in Indian clinical practice as a safe postpartum option for breastfeeding women. Still, discuss your individual situation with your clinician. (3) (2)

What is the dosing schedule for ormeloxifene as a contraceptive?

The approved Indian regimen is two 30 mg tablets per week for the first 12 weeks, then one tablet once a week from the fourth month onward, for as long as contraception is needed. Additional barrier contraception is generally advised during the first 8 weeks. (3) (1)

What is the mechanism of action of ormeloxifene (centchroman)?

Ormeloxifene is a selective estrogen receptor modulator (SERM), acting as an estrogen-receptor antagonist in the uterus/endometrium and breast tissue while behaving as a weak estrogen agonist in bone. Its main contraceptive mechanism is inhibition of blastocyst implantation via effects on endometrial receptivity, without suppression of ovulation or disruption of the hypothalamic-pituitary-ovarian axis. (2) (1)

What is the generic name of Ormeloxifene?

The generic name is ormeloxifene (centchroman). (1) (2)

What class of drug is ormeloxifene (centchroman)?

Ormeloxifene is classed as: Selective estrogen receptor modulator (SERM) -- non-hormonal, non-steroidal oral contraceptive / uterine-bleeding agent. (1) (2)

References

  1. World's first non-steroidal birth control pill -- CSIR success storyCouncil of Scientific and Industrial Research (CSIR) -- Indian government scientific research organisation, parent body of CDRI Lucknow which developed the drug · India · accessed 2026-07-30 · source 1
  2. Assessing the Acceptance of and Compliance With Centchroman Usage, a Non-hormonal Contraceptive Pill, Among Postpartum Women: A Cross-Sectional Study at a Tertiary Care Centre in North IndiaPeer-reviewed clinical study, Cureus (Springer Nature), authored by clinicians at All India Institute of Medical Sciences (AIIMS) New Delhi, Department of Obstetrics and Gynaecology, with WHO Country Office for India co-authorship · India · accessed 2026-07-30 · source 2
  3. Centchroman (Ormeloxifene) -- dosing schedule, side effects, pregnancy/lactation guidance1mg -- Indian consumer/clinical drug-information aggregator, commonly used as a practical reference for Indian-market drug information in the absence of a public government label database · India · accessed 2026-07-30 · source 3
  4. DailyMed search for 'ormeloxifene' -- zero resultsDailyMed (U.S. National Library of Medicine) -- product label search · United States · accessed 2026-07-30 · source 4
  5. emc.medicines.org.uk search for 'ormeloxifene' -- zero resultselectronic medicines compendium (emc), United Kingdom -- product search · United Kingdom · accessed 2026-07-30 · source 5
  6. TGA PICMI search for 'ormeloxifene' -- zero documentsTherapeutic Goods Administration (TGA), Australia -- PI & CMI product search · Australia · accessed 2026-07-30 · source 6
  7. EMA medicine search for 'ormeloxifene' -- technical failure (HTTP 401)n/a -- disclosed live-query technical failure, not a confirmed negative or positive result · European Union · accessed 2026-07-30 · source 7
  8. Health Canada Drug Product Database search for 'ormeloxifene' -- technical failure (HTTP 405)n/a -- disclosed live-query technical failure, not a confirmed negative or positive result · Canada · accessed 2026-07-30 · source 8
  9. Medsafe product/trade-name search for 'ormeloxifene' -- form-based search, no direct result page capturedn/a -- disclosed live-query limitation, not a confirmed negative or positive result · New Zealand · accessed 2026-07-30 · source 9

Brand names by country

Single-ingredient ormeloxifene (centchroman) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

India

  • NovexHindustan Latex Ltd
  • SevistaTorrent Pharmaceuticals Ltd
  • OrmefenKoye Pharmaceuticals Pvt Ltd
  • OrsermPharmanova India Drugs Pvt Ltd
  • Genlox DSGynogen
  • Centron PlusTorrent Pharmaceuticals Ltd
  • DubalexCheminnova Life Sciences
  • OrmexiPride Healthcare
  • OrmalinCipla Ltd
  • Ormi-RideQuinek Life Sciences
View brands in additional countries.

This page provides general reference information about ormeloxifene, a medicine authorised only in India, and is not a substitute for advice from a pharmacist or doctor. It is not an approved medicine in the United States, United Kingdom, European Union, Canada, Australia, or New Zealand. All dosing and treatment decisions should be made with a qualified clinician or through the national family-planning programme supplying this medicine in India.

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