Clinical trial NCT00005104: Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Hyperinsulinism
Keywords: endocrine disorders
hyperinsulinism
polycystic ovarian syndrome
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Virginia
First posted: 2000-04-07
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

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

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Shreveport
country: United States
facility: Louisiana State University School of Medicine
state: Louisiana
city: St. Louis
country: United States
facility: Washington University - St. Louis
state: Missouri
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Medical College of Virginia School of Medicine
state: Virginia
city: Bologna
country: Italy
facility: University Alma Mater
Study officials:
affiliation: University of Virginia
name: William S. Evans
role: STUDY_CHAIR
References: