Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-03-31

Brief Summary

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

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Detailed Description

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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

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Polycystic Ovarian Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Raloxifene

3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7

Group Type EXPERIMENTAL

Raloxifene

Intervention Type DRUG

Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal

Clomiphene

3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7

Group Type ACTIVE_COMPARATOR

Clomiphene

Intervention Type DRUG

Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal

Interventions

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Raloxifene

Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Provera Provera

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No