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Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome (PCOS)
This study has been terminated.
(Over budget, slow recruitment, and personnel change)
Sponsor:
Bruce Lessey
Information provided by (Responsible Party):
Bruce Lessey, Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:
NCT01607320
First received: February 15, 2012
Last updated: May 12, 2015
Last verified: May 2015
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Purpose
This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).
| Condition | Intervention |
|---|---|
| Polycystic Ovarian Syndrome | Drug: Raloxifene Drug: Clomiphene |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome. |
Resource links provided by NLM:
Further study details as provided by Bruce Lessey, Greenville Hospital System University Medical Center:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Ovulation [ Time Frame: Cycle day 22-24 ]If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.
| Enrollment: | 3 |
| Study Start Date: | June 2012 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Raloxifene
3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7
|
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
|
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
|
Detailed Description:
Clomiphene citrate (CC) is the major pharmaceutical treatment of anovulation in polycystic ovary syndrome, used for over 40 years. Despite the vast experience using this drug, the pregnancy rates associated with its use are low and recent large studies from Australia regarding birth defects suggest that CC may be associated with birth defects. Alternatives to CC are limited. Another selective estrogen receptor modulator, Raloxifene (RAL) does not have the long half life exhibited by CC, and has recently been shown to be equivalent to CC in terms of ability to induce ovulation in PCOS women. In addition, prior studies have demonstrated potential benefits on markers of uterine receptivity in a cell line model by blocking estrogen activity. Beyond this, there are no studies to examine whether Raloxifene is an effective oral agent for the treatment of women desiring pregnancy, but the investigators' hypothesis is that Raloxifene will work as well as CC but be better at establishment and maintenance of pregnancy than CC
Eligibility| Ages Eligible for Study: | 18 Years to 36 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
-
Diabetes Mellitus
- Any subject on Metformin must "wash out" for 30 days prior to screening
- History of endometriosis
- Known male factor infertility
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01607320
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607320
Locations
| United States, South Carolina | |
| Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
Sponsors and Collaborators
Bruce Lessey
Investigators
| Principal Investigator: | Bruce A. Lessey, MD, PhD | Greenville Hospital System |
More Information
| Responsible Party: | Bruce Lessey, MD, PhD. and Professor of Clinical Obstetrics & Gynecology, Dept of OB/GYN, Greenville Hospital System University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01607320 History of Changes |
| Other Study ID Numbers: |
9469 |
| Study First Received: | February 15, 2012 |
| Results First Received: | April 14, 2015 |
| Last Updated: | May 12, 2015 |
Keywords provided by Bruce Lessey, Greenville Hospital System University Medical Center:
|
PCOS Infertility Anovulation |
Additional relevant MeSH terms:
|
Syndrome Polycystic Ovary Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Clomiphene Enclomiphene Zuclomiphene |
Raloxifene Hydrochloride Medroxyprogesterone Acetate 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, Female Contraceptive Agents |
ClinicalTrials.gov processed this record on July 24, 2017