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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 : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Lessey, Prisma Health-Upstate

Tracking Information
First Submitted Date  ICMJE February 15, 2012
First Posted Date  ICMJE May 30, 2012
Results First Submitted Date  ICMJE April 14, 2015
Results First Posted Date  ICMJE June 1, 2015
Last Update Posted Date September 20, 2018
Study Start Date  ICMJE June 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2012)
Ovulation [ Time Frame: Cycle day 22-24 ]
If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome
Official Title  ICMJE Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome.
Brief Summary This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovarian Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Raloxifene
    3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7
    Intervention: Drug: Raloxifene
  • Active Comparator: Clomiphene
    3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7
    Intervention: Drug: Clomiphene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 12, 2015)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2012)
60
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 36 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01607320
Other Study ID Numbers  ICMJE 9469
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruce Lessey, Prisma Health-Upstate
Study Sponsor  ICMJE Bruce Lessey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruce A. Lessey, MD, PhD Greenville Hospital System
PRS Account Prisma Health-Upstate
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP