NCT00004763

Brief Summary

OBJECTIVES: I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

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, 1993

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2001

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Hyperandrogenism

Keywords

endocrine disordershyperandrogenismrare disease

Interventions

leuprolideDRUG
Ethinyl estradiol/norethindroneDRUG

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
PROTOCOL ENTRY CRITERIA: Disease Characteristics * Ovarian hyperandrogenism with Lorenzo hirsutism score 7 to 20, with or without severe acne * Serum hormone levels: Follicle-stimulating hormone no greater than 40 mIU/mL Luteinizing hormone no greater than 40 mIU/mL Testosterone 60 to 200 ng/dL Dehydroepiandrosterone sulfate no greater than 430 micrograms/dL 17-hydroxyprogesterone no greater than 3.3 ng/mL in follicular phase Prolactin no greater than 18 ng/dL * No adrenal or ovarian tumors Prior/Concurrent Therapy * At least 6 months since exogenous steroids At least 48 hours since drugs other than acetaminophen, ibuprofen, and aspirin Patient Characteristics * No malignancy, including the following carcinomas: Breast Cervix Ovary Uterus No other serious illness No cigarette smokers No nursing women No pregnancy within 6 months prior to entry

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

Sponsors & Collaborators

MeSH Terms

Conditions

HyperandrogenismEndocrine System DiseasesRare Diseases

Interventions

Leuprolideovcon 35

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Karen E. Elkind-Hirsch

    Baylor College of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

January 1, 1993

Last Updated

June 24, 2005

Record last verified: 2001-12