NCT00005104

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

April 6, 2000

Last Update Submit

June 23, 2005

Conditions

Polycystic Ovary SyndromeHyperinsulinism

Keywords

endocrine disordershyperinsulinismpolycystic ovarian syndromerare disease

Interventions

clomiphene citrateDRUG
metforminDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Louisiana State University School of Medicine

Shreveport, Louisiana, 71130-3932, United States

Location

Washington University - St. Louis

St Louis, Missouri, 63110, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Medical College of Virginia School of Medicine

Richmond, Virginia, 23298-0230, United States

Location

University Alma Mater

Bologna, 40100, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeHyperinsulinismEndocrine System DiseasesRare Diseases

Interventions

ClomipheneMetformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBiguanidesGuanidinesAmidines

Study Officials

  • William S. Evans

    University of Virginia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 6, 2000

First Posted

April 7, 2000

Study Start

January 1, 2000

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(5)IT(1)