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Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004763
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperandrogenism
 Drug: leuprolide
Drug: Ethinyl estradiol/norethindrone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 45
Study Start Date: January 1993
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004763

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Baylor College of Medicine
Investigators
Study Chair: Karen E. Elkind-Hirsch Baylor College of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004763     History of Changes
Other Study ID Numbers: 199/11717, BCM-11717
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
endocrine disorders
hyperandrogenism
rare disease

Additional relevant MeSH terms:
Hyperandrogenism
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
Contraceptive Agents
Norethindrone
Norethindrone acetate
Norinyl
Ethynylestradiol mixture with norethindrone
Contraceptives, Oral
Estradiol
 Ethinyl Estradiol
Mestranol
Leuprolide
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential

ClinicalTrials.gov processed this record on May 23, 2013