Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome

Sponsor

National Center for Research Resources (NCRR) (NIH)

Overall Status

Completed

CT.gov ID

NCT00005104

Collaborator

University of Virginia (Other)

Enrollment

Locations

16.5

Patients Per Site

Study Details

Study Description

Brief Summary

OBJECTIVES:

Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Hyperinsulinism	Drug: clomiphene citrate Drug: metformin	N/A

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms.

Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110. Following ovulation, treatment with clomiphene citrate and metformin or placebo continues until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate may be crossed over to receive metformin after a 6 week washout.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Patients with chronic anovulation due to polycystic ovary syndrome (PCOS) who have failed clomiphene citrate

Must have oligoovulation and hyperandrogenemia

--Prior/Concurrent Therapy--

Endocrine therapy: At least 2 months since prior clomiphene citrate

Other:

At least 2 months since prior standard therapy (including over the counter drugs)
At least 2 months since prior investigational drugs
Prior multi/prenatal vitamins allowed

--Patient Characteristics--

Hematopoietic: Hematocrit greater than 38%

Hepatic:

Liver function normal
No clinically significant hepatic disease

Renal:

No clinically significant renal disease
Creatinine less than 1.4 mg/dL
No proteinuria

Cardiovascular: No clinically significant cardiac disease

Pulmonary: No clinically significant pulmonary disease

Hormonal:

Thyroid function normal
Prolactin normal
Estradiol normal
Fasting 17 alpha-hydroxy progesterone less than 200 ng/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency

Other:

Not pregnant
Negative pregnancy test
Male partner must have a normal semen analysis by WHO criteria
Must be in acceptable health by interview, medical history, physical exam, and laboratory tests
No diabetes mellitus
No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease
No clinically significant malignant disease except nonmelanomatous skin cancer
At least 1 year since any prior drug abuse or alcoholism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3300
2	Louisiana State University School of Medicine	Shreveport	Louisiana	United States	71130-3932
3	Washington University - St. Louis	St. Louis	Missouri	United States	63110
4	University of Virginia	Charlottesville	Virginia	United States	22908
5	Medical College of Virginia School of Medicine	Richmond	Virginia	United States	23298-0230
6	University Alma Mater	Bologna		Italy	40100