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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:
Information provided by (Responsible Party):
Bruce Lessey, Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:
NCT01607320
First received: February 15, 2012
Last updated: August 20, 2013
Last verified: August 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Greenville Hospital System University Medical Center:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.
Enrollment: 1
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
Genders 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
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, see Learn About Clinical Studies.

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

No publications provided

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
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Greenville Hospital System University Medical Center:
PCOS
Infertility
Anovulation

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Clomiphene
Medroxyprogesterone
Medroxyprogesterone Acetate
 Raloxifene
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 27, 2015