NCT01607320

Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Bruce Lessey · Academic / Other
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

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

Conditions

• Polycystic Ovarian Syndrome

Interventions

Type	Name	Description
DRUG	Raloxifene	Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal
DRUG	Clomiphene	Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-05-30
• Last updated: 2018-09-20
• Results posted: 2015-06-01

Locations

1 site across 1 country: United States