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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 : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Lessey, Greenville Health System

Study Description
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Brief Summary:
This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Drug: Raloxifene Drug: Clomiphene Not Applicable

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

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Ovulation [ Time Frame: Cycle day 22-24 ]
    If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged 18 to 36
  2. BMI > 19 & < 40
  3. 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:

  1. Use of ovulation induction agents within the past 6 months
  2. Positive pregnancy test before taking study medications
  3. History or current thromboembolic disorder
  4. Coronary artery disease such as heart attack or stroke
  5. Tobacco use or history within the past 6 months
  6. History of pelvic inflammatory disease and tubal factor infertility
  7. Congenital adrenal hyperplasia

  8. Diabetes Mellitus

    • Any subject on Metformin must "wash out" for 30 days prior to screening
  9. History of endometriosis
  10. Known male factor infertility
Contacts and Locations
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Information from the National Library of Medicine

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


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
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Responsible Party: Bruce Lessey, MD, PhD. and Professor of Clinical Obstetrics & Gynecology, Dept of OB/GYN, Greenville Health System
ClinicalTrials.gov Identifier: NCT01607320     History of Changes
Other Study ID Numbers: 9469
First Posted: May 30, 2012    Key Record Dates
Results First Posted: June 1, 2015
Last Update Posted: March 20, 2018
Last Verified: February 2018

Keywords provided by Bruce Lessey, Greenville Health System:
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