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Home > "L" Clinical Trials Conditions > Leuprolide in Treating Adults With Hypogonadotropism  Leuprolide in Treating Adults With Hypogonadotropism
Leuprolide in Treating Adults With Hypogonadotropism
For Condition: Hypogonadism
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of Chicago
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/35 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 45
Location and Contact Information:
Overall Study Official:
RobertRosenfield, Study Chair, University of Chicago
University of Chicago Children's Hospital *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Robert Rosenfield 773-702-6432
Additional Information:
Study ID Numbers: 199/13402; UCCH-8451,UCCH-FDR001473
Study Start Date: September 1997
Record last reviewed: June 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004438
Other Hypogonadism Studies:
1. Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
2. Testosterone and Growth Hormone for Bone Loss in Men
3. Leuprolide in Treating Adults With Hypogonadotropism
4. Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men with Hypogonadism
5. Leuprolide in Determining the Cause of Gonadotropin Deficiency
Related Studies:
Other Hypogonadism Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Leuprolide in Treating Adults With Hypogonadotropism
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