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Leuprolide in Treating Adults With Hypogonadotropism

This study is currently recruiting patients.

Sponsored by: FDA Office of Orphan Products Development
University of Chicago
Information provided by: FDA Office of Orphan Products Development

Purpose

RATIONALE: Hypogonadotropism is an abnormal condition caused by decreased production of gonadotropins, a group of hormones that stimulate the parts of the reproductive system that produce and release eggs from the ovaries or sperm from the testicles. Leuprolide may stimulate the production of gonadotropins and be effective in increasing testosterone in men and inducing ovulation in women.

PURPOSE: Clinical trial to study the effectiveness of leuprolide in treating adults who have hypogonadotropism.

Condition Treatment or Intervention
Hypogonadism
 Drug: leuprolide

MedlinePlus related topics:  Endocrine Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Study of Leuprolide in Adults with Hypogonadotropism

Further Study Details: 

Expected Total Enrollment:  45

Study start: September 1997

PROTOCOL OUTLINE: Male patients receive leuprolide subcutaneously every 5 days for up to one year and are followed at weeks 4, 6, 8, and 12, then every 2 months. Female patients receive leuprolide subcutaneously on days 1, 6, and possibly 11. Patients are followed 2 months after the last injection.

Eligibility

Ages Eligible for Study:  18 Years   -   35 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of hypogonadotropism

Men: Small testes, abnormal semen analysis, and subnormal plasma testosterone levels without an elevation in gonadotropin levels

Women: Amenorrhea and subnormal plasma estradiol levels, or lack of cornification of the vaginal mucosa without an elevation in gonadotropin levels OR Hypothalamic amenorrhea in normally estrogenized women with amenorrhea or oligomenorrhea and normal plasma free testosterone and gonadotropin levels

Patients with hyperprolactinemia eligible only if hypogonadotropism persists after correction of hyperprolactinemia by dopamine agonist therapy

--Prior/Concurrent Therapy-- At least 2 months since sex hormone treatment

--Patient Characteristics--

Other:


Location and Contact Information


Illinois
      University of Chicago Children's Hospital, Chicago,  Illinois,  60637,  United States; Recruiting
Robert L. Rosenfield  773-702-6432 

Study chairs or principal investigators

Robert L. Rosenfield,  Study Chair,  University of Chicago   

More Information

Study ID Numbers:  199/13402; UCCH-8451; UCCH-FDR001473
Record last reviewed:  June 1998
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004438
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09
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