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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
  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:


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   (Child, Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Leuprolide
Norinyl
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norethindrone
Norethindrone acetate
Ethinyl Estradiol
Estradiol
Mestranol
Contraceptives, Oral
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Combined
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Oral, Hormonal

ClinicalTrials.gov processed this record on June 28, 2017