Leuprolide in Treating Adults With Hypogonadotropism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 1998 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Chicago
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004438
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: June 1998

October 18, 1999
June 23, 2005
September 1997
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Complete list of historical versions of study NCT00004438 on ClinicalTrials.gov Archive Site
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Leuprolide in Treating Adults With Hypogonadotropism
Study of Leuprolide in Adults With Hypogonadotropism

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.

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.

Interventional
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Primary Purpose: Treatment
Hypogonadism
Drug: leuprolide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
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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:

  • Not pregnant
  • No chronic systemic, metabolic, or endocrine disease
Both
18 Years to 35 Years
No
Not Provided
United States
 
NCT00004438
199/13402, UCCH-8451, UCCH-FDR001473
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FDA Office of Orphan Products Development
University of Chicago
Study Chair: Robert L. Rosenfield University of Chicago
FDA Office of Orphan Products Development
June 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP