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Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome.

18 Years
36 Years
Open (Enrolling)
Polycystic Ovarian Syndrome

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Trial Information

Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Bruce A. Lessey, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Greenville Hospital System


United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

January 2014

Related Keywords:

  • Polycystic Ovarian Syndrome
  • PCOS
  • Infertility
  • Anovulation
  • Polycystic Ovary Syndrome



Greenville Hospital SystemGreenville, South Carolina  29605