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
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:
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
- Not pregnant
- No chronic systemic, metabolic, or endocrine disease