Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bruce Lessey
• Treatments: Clomiphene; Enclomiphene; Medroxyprogesterone; Medroxyprogesterone Acetate; Raloxifene Hydrochloride; Zuclomiphene

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