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
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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
No
Bruce A. Lessey, MD, PhD
Principal Investigator
Greenville Hospital System
United States: Food and Drug Administration
9469
NCT01607320
June 2012
January 2014
Name | Location |
---|---|
Greenville Hospital System | Greenville, South Carolina 29605 |