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| Sponsors and Collaborators: |
FDA Office of Orphan Products Development University of Chicago |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004438 |
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 | Intervention |
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Hypogonadism |
Drug: leuprolide |
| Drug Information available for: | Leuprolide acetate Leuprolide |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Study of Leuprolide in Adults With Hypogonadotropism |
| Estimated Enrollment: | 45 |
| Study Start Date: | 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 to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| United States, Illinois | |||||
| University of Chicago Children's Hospital | Recruiting | ||||
| Chicago, Illinois, United States, 60637 | |||||
| Contact: Robert L. Rosenfield 773-702-6432 | |||||
| FDA Office of Orphan Products Development |
| University of Chicago |
| Study Chair: | Robert L. Rosenfield | University of Chicago |
More Information
| Study ID Numbers: | 199/13402, UCCH-8451, UCCH-FDR001473 |
| First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004438 |
| Health Authority: | United States: Federal Government |
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