NCT00005654

Brief Summary

OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2000

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2000

First QC Date

May 2, 2000

Last Update Submit

June 23, 2005

Conditions

HyperinsulinismPolycystic Ovary Syndrome

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-- Obese women with chronic anovulation due to polycystic ovary syndrome (PCOS) Must have oligoamenorrhea and hyperandrogenemia --Prior/Concurrent Therapy-- At least 2 months since prior standard therapy (including over the counter drugs) At least 2 months since prior investigational agents --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 Fasting 17 alpha-hydroxy progesterone less than 200 mg/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception 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

MeSH Terms

Conditions

HyperinsulinismPolycystic Ovary SyndromeEndocrine System DiseasesRare Diseases

Interventions

ClomipheneMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersDisease 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

May 2, 2000

First Posted

May 3, 2000

Study Start

January 1, 2000

Last Updated

June 24, 2005

Record last verified: 2000-04