Leuprolide in Treating Adults With Hypogonadotropism
Leuprolide in Treating Adults With Hypogonadotropism
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.
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
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