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Leuprolide in Treating Adults With Hypogonadotropism

Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: leuprolide (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Robert L. Rosenfield, Study Chair, Affiliation: University of Chicago


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.

Clinical Details

Official title: Study of Leuprolide in Adults With Hypogonadotropism

Study design: Primary Purpose: Treatment

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


Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Both.



- -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--


- Not pregnant

- No chronic systemic, metabolic, or endocrine disease

Locations and Contacts

University of Chicago Children's Hospital, Chicago, Illinois 60637, United States
Additional Information

Starting date: September 1997
Last updated: March 24, 2015

Page last updated: August 23, 2015

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