Leuprolide in Determining the Cause of Gonadotropin Deficiency
Recruitment status was Recruiting
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Purpose
RATIONALE: The body's response to one injection of leuprolide may provide more information than the standard test for gonadotropin deficiency in determining whether the cause of gonadotropin deficiency is related to the hypothalamus or the pituitary gland.
PURPOSE: Randomized double-blinded clinical trial to study the effectiveness of leuprolide in determining the cause of gonadotropin deficiency.
| Condition | Intervention |
|---|---|
|
Hypogonadism |
Drug: gonadotropin releasing hormone Drug: leuprolide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Study of Gonadotropin Releasing Hormone Agonist Test Using Leuprolide Acetate in Patients With Gonadotropin Deficiency |
| Estimated Enrollment: | 90 |
| Study Start Date: | December 1999 |
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive leuprolide acetate or gonadotropin releasing hormone (GnRH) first, then cross over to receive the other test.
Patients receive one subcutaneous injection of leuprolide acetate or GnRH, then have blood samples drawn periodically. One month later, patients receive the other test.
Another cohort of patients are randomized to receive leuprolide acetate once daily on days 0, 4, and 8, or days 0, 5, and 10.
Patients are followed for up to 2 years.
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Prepubertal children with constitutionally delayed puberty At least 2 years retardation of bone age Spontaneously progress into puberty within 1 year Boys: Testes long diameter 2.5-3.5 cm and plasma testosterone 40-300 ng/dL Girls: Breast development, but premenarcheal OR Hypogonadotropinism Delayed onset of pubertal milestones associated with anterior panhypopituitarism OR Kallman's syndrome No spontaneous progression into puberty within 2 years after 6 months replacement sex steroid treatment
--Prior/Concurrent Therapy--
- At least 2 months since prior sex hormone treatment
--Patient Characteristics--
- Age: 14-18 for children with hypogonadotropinism 9-13 for normal children
- Other: No chronic systemic disease No metabolic disease No endocrine disease No growth hormone deficiency
Contacts and Locations| United States, Illinois | |
| University of Chicago Children's Hospital | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Robert L. Rosenfield 773-702-6432 | |
| Study Chair: | Robert L. Rosenfield | University of Chicago |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004426 History of Changes |
| Other Study ID Numbers: | 199/13361, UCCH-FDR001012 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by FDA Office of Orphan Products Development:
|
endocrine disorders hypogonadism rare disease |
Additional relevant MeSH terms:
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Hormones Leuprolide Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Fertility Agents, Female Fertility Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 23, 2013