Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome (PCOS)
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ClinicalTrials.gov Identifier: NCT01607320 |
Recruitment Status :
Terminated
(Over budget, slow recruitment, and personnel change)
First Posted : May 30, 2012
Results First Posted : June 1, 2015
Last Update Posted : September 20, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovarian Syndrome | Drug: Raloxifene Drug: Clomiphene | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome. |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Raloxifene
3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7
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Drug: Raloxifene
Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal
Other Name: Provera |
Active Comparator: Clomiphene
3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7
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Drug: Clomiphene
Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
Other Name: Provera |
- Pregnancy [ Time Frame: 4 months ]Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.
- Ovulation [ Time Frame: Cycle day 22-24 ]If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 36 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women aged 18 to 36
- BMI > 19 & < 40
- PCOS diagnosis as evidenced by:
Oligo- and/or anovulation (< 6 cycles per year) and one of the following:
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumors, Cushing's syndrome)
Exclusion Criteria:
- Use of ovulation induction agents within the past 6 months
- Positive pregnancy test before taking study medications
- History or current thromboembolic disorder
- Coronary artery disease such as heart attack or stroke
- Tobacco use or history within the past 6 months
- History of pelvic inflammatory disease and tubal factor infertility
- Congenital adrenal hyperplasia
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Diabetes Mellitus
- Any subject on Metformin must "wash out" for 30 days prior to screening
- History of endometriosis
- Known male factor infertility

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607320
United States, South Carolina | |
Greenville Hospital System | |
Greenville, South Carolina, United States, 29605 |
Principal Investigator: | Bruce A. Lessey, MD, PhD | Greenville Hospital System |
Responsible Party: | Bruce Lessey, MD, PhD. and Professor of Clinical Obstetrics & Gynecology, Dept of OB/GYN, Prisma Health-Upstate |
ClinicalTrials.gov Identifier: | NCT01607320 |
Other Study ID Numbers: |
9469 |
First Posted: | May 30, 2012 Key Record Dates |
Results First Posted: | June 1, 2015 |
Last Update Posted: | September 20, 2018 |
Last Verified: | August 2018 |
PCOS Infertility Anovulation |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Raloxifene Hydrochloride Medroxyprogesterone Acetate Clomiphene Medroxyprogesterone |
Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Contraceptive Agents, Hormonal Contraceptive Agents Contraceptive Agents, Female Contraceptive Agents, Male Antineoplastic Agents, Hormonal |