Completed

Study of Leuprolide in Adults With Hypogonadotropism

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What is being tested

leuprolide

Drug
Who is being recruted

Gonadal Disorders+4

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

From 18 to 35 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 1997
See protocol details

Summary

Principal SponsorUniversity of Chicago
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1997

Actual date on which the first participant was enrolled.

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

NCT00004438
Principal SponsorUniversity of Chicago
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Gonadal DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesEndocrine System DiseasesHypogonadismRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Chicago Children's Hospital

Chicago, United StatesOpen University of Chicago Children's Hospital in Google Maps
CompletedOne Study Center