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Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

Information source: Greenville Hospital System University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovarian Syndrome

Intervention: Raloxifene (Drug); Clomiphene (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Bruce Lessey

Official(s) and/or principal investigator(s):
Bruce A. Lessey, MD, PhD, Principal Investigator, Affiliation: Greenville Hospital System

Summary

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

Clinical Details

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

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

Primary outcome: Pregnancy

Secondary outcome: Ovulation

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

Eligibility

Minimum age: 18 Years. Maximum age: 36 Years. Gender(s): Female.

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

Locations and Contacts

Greenville Hospital System, Greenville, South Carolina 29605, United States
Additional Information

Starting date: June 2012
Last updated: May 12, 2015

Page last updated: August 23, 2015

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