Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

Not Applicable

Terminated

• Conditions: Polycystic Ovarian Syndrome
• Interventions: Drug: Clomiphene; Drug: Raloxifene

• Registration Number: NCT01607320
• Lead Sponsor: Bruce Lessey

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 Timeline

• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-30
• Study Start: 2012-06
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2015-04-14
• Results First Submitted QC: 2015-05-12
• Results First Posted: 2015-06-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clomiphene	Clomiphene	3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7
Raloxifene	Raloxifene	3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7

Primary Outcome Measures

Name	Time	Method
Pregnancy	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

Name	Time	Method
Ovulation	Cycle day 22-24	If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.

Trial Locations

Locations (1)

Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States