Leuprolide in Treating Adults With Hypogonadotropism

The University of Chicago

Status: Completed

Conditions: Hypogonadism

Treatments: Drug: leuprolide

Study type: Interventional

Funder types: Other

Identifiers

NCT00004438

UCCH-FDR001473

UCCH-8451

199/13402

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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