Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

Polycystic Ovarian Syndrome Clinical Trial

— PCOS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01607320
• Other study ID #: 9469
• Status: Terminated
• Phase: N/A
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2018
• Source: Greenville Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Greenville Hospital System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bruce Lessey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ovulation	If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.	Cycle day 22-24