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Hormone Therapy

Group 1 (FSH) for Low Testosterone

Phase 2
Waitlist Available
Led By William F Crowley, Jr., MD
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

Men with idiopathic hypogonadotropic hypogonadism (IHH, Kallmann Syndrome) may have small testicular size, low testosterone levels, no history of puberty, and infertility. These men lack a hormone called gonadotropin releasing hormone (GnRH) that stimulates the development and maturation of the testes. This study will investigate the impact of hormonal treatments on men with IHH. The goal of hormonal therapy is to maximize the potential fertility in these individuals.

Eligible Conditions
  • Low Testosterone
  • Kallmann Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
FSH
Inhibin B
LH
+3 more
Secondary outcome measures
Fertility

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 (FSH)Experimental Treatment3 Interventions
Patients in Group 1 will receive subcutaneous follicle stimulating hormone (FSH) injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive gonadotropin releasing hormone (GnRH) therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
Group II: Group 2 (GnRH)Active Control2 Interventions
Patients in Group 2 will receive gonadotropin releasing hormone (GnRH) therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gonadorelin
FDA approved
Testicular biopsy
2014
N/A
~140

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,976 Previous Clinical Trials
2,680,730 Total Patients Enrolled
William F Crowley, Jr., MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
175 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism
William Crowley 2001. "Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00064987.
~1 spots leftby May 2025
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