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Leuprolide in Treating Adults With Hypogonadotropism
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development University of Chicago
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Information provided by: | FDA Office of Orphan Products Development |
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 | Treatment or Intervention |
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Hypogonadism |
Drug: leuprolide |
MedlinePlus related topics: Endocrine Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Study of Leuprolide in Adults with Hypogonadotropism
Expected Total Enrollment: 45
Study start: 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 - 35 Years, Genders Eligible for Study: Both
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:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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