Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

Study Overview
=================
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

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

Conditions
-----------------
Polycystic Ovarian Syndrome

Intervention / Treatment
-----------------
* Drug: Raloxifene
* Drug: Clomiphene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18 to 36 BMI > 19 & < 40 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: Use of ovulation induction agents within the past 6 months Positive pregnancy test before taking study medications History or current thromboembolic disorder Coronary artery disease such as heart attack or stroke Tobacco use or history within the past 6 months History of pelvic inflammatory disease and tubal factor infertility Congenital adrenal hyperplasia Diabetes Mellitus Any subject on Metformin must wash out for 30 days prior to screening History of endometriosis Known male factor infertility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raloxifene<br>3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 | Drug: Raloxifene<br>* Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal<br>* Other names: Provera;|
| Active Comparator: Clomiphene<br>3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 | Drug: Clomiphene<br>* Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal<br>* Other names: Provera;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation | If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study. | Cycle day 22-24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, Infertility, Anovulation