NCT00004438

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 1997

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
Last Updated

March 25, 2015

Status Verified

June 1, 1998

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Hypogonadism

Keywords

endocrine disordershypogonadismrare disease

Interventions

leuprolideDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Children's Hospital

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

HypogonadismEndocrine System DiseasesRare Diseases

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Gonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Robert L. Rosenfield

    University of Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

September 1, 1997

Study Completion

September 1, 2002

Last Updated

March 25, 2015

Record last verified: 1998-06

Locations

US(1)