Completed

Leuprolide vs Oral Contraceptive Therapy for Ovarian Hyperandrogenism

Study Aim

This phase 2 study aims to compare the effectiveness of Leuprolide and Oral Contraceptive Therapy in managing ovarian hyperandrogenism.

What is being tested

leuprolide

+ Ethinyl estradiol/norethindrone

Drug

Who is being recruted

Congenital Abnormalities+14

+ Urogenital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 15 to 40 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: January 1993

See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1993

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to a 6-month course of leuprolide versus ethinyl estradiol/norethindrone (Ovcon 35) versus leuprolide plus Ovcon 35. Leuprolide is administered intramuscularly in depot form every 28 days.

NCT00004763

Principal SponsorNational Center for Research Resources (NCRR)

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 15 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesUrogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesDisorders of Sex DevelopmentPathological Conditions, Signs and SymptomsUrogenital AbnormalitiesDisease AttributesAdrenogenital SyndromeFemale Urogenital DiseasesMale Urogenital Diseases46, XX Disorders of Sex DevelopmentEndocrine System DiseasesHyperandrogenismRare Diseases

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers