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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Baylor College of Medicine
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004763

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 II

Drug Information available for: Estradiol Estradiol 3-benzoate Norethindrone acetate Ethinyl estradiol Norethindrone Polyestradiol phosphate Leuprolide Depogen Leuprolide acetate Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

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

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

Keywords provided by Office of Rare Diseases (ORD):

endocrine disorders
hyperandrogenism
rare disease

Study placed in the following topic categories:

Modicon
Contraceptive Agents
Gonadal Disorders
Hormone Antagonists
Contraceptives, Oral
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Hyperandrogenism
Estradiol 17 beta-cypionate
Sex Differentiation Disorders
Hormones
Contraceptives, Oral, Sequential
Leuprolide
Norethindrone

Estradiol 3-benzoate
Polyestradiol phosphate
Estrogens
Antineoplastic Agents, Hormonal
Rare Diseases
Endocrine System Diseases
Ethinyl Estradiol
Norinyl
Estradiol
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Mestranol
Endocrinopathy
Norethindrone acetate

Additional relevant MeSH terms:

Modicon
Antineoplastic Agents
Gonadal Disorders
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Hyperandrogenism
Reproductive Control Agents
Sex Differentiation Disorders
Hormones
Contraceptives, Oral, Sequential
Leuprolide
Norethindrone

Therapeutic Uses
Contraceptives, Oral, Synthetic
Estrogens
Antineoplastic Agents, Hormonal
Ethinyl Estradiol
Endocrine System Diseases
Norinyl
Estradiol
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Fertility Agents, Female
Fertility Agents
Mestranol
Norethindrone acetate

ClinicalTrials.gov processed this record on May 07, 2009