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Leuprolide in Treating Adults With Hypogonadotropism

Primary Purpose

Hypogonadism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
leuprolide
Sponsored by
University of Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring endocrine disorders, hypogonadism, rare disease

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Children's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
March 24, 2015
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00004438
Brief Title
Leuprolide in Treating Adults With Hypogonadotropism
Official Title
Study of Leuprolide in Adults With Hypogonadotropism
Study Type
Interventional

2. Study Status

Record Verification Date
June 1998
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Chicago

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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. Completion date provided represents the completion date of the grant per OOPD records

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
endocrine disorders, hypogonadism, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
leuprolide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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: Not pregnant No chronic systemic, metabolic, or endocrine disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Rosenfield
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Leuprolide in Treating Adults With Hypogonadotropism

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