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Hormone Therapy

Pulsatile GnRH for Hypogonadotropic Hypogonadism

Phase 2
Waitlist Available
Led By Janet E Hall, M.D.
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1st 7 days of treatment
Awards & highlights

Study Summary

The purpose of this study is to explore the effects of synthetic gonadotropin-releasing hormone (GnRH) upon the pituitary and ovaries of women with infertility. Women diagnosed with GnRH deficiency, hypothalamic amenorrhea or acquired hypogonadic hypogonadism, will participate in this study. It is hoped that administration of GnRH will lead to proper stimulation of the pituitary gland and to normal ovulation and menstruation. **WE ARE CURRENTLY RECRUITING ONLY WOMEN WITH A DIAGNOSIS OF IDIOPATHIC HYPOGONADIC HYPOGONADISM (IHH)** Pulsatile GnRH has been approved by the FDA for use in women with primary amenorrhea due to complete GnRH deficiency. The overall goals of this protocol are to continue to use pulsatile GnRH in GnRH-deficient and other anovulatory women for ovulation induction and to examine specific physiologic hypotheses, which can only be addressed in this patient population.

Eligible Conditions
  • Hypogonadotropic Hypogonadism
  • Amenorrhea
  • Olfacto-Genital Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1st 7 days of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1st 7 days of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ovulation
Secondary outcome measures
pregnancy
Other outcome measures
FSH
LH

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pulsatile GnRHExperimental Treatment2 Interventions
All participants will be administered GnRH intravenously by means of a portable infusion pump that delivers boluses at specific intervals.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pump
2013
N/A
~360
Gonadorelin
FDA approved

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,970 Previous Clinical Trials
2,677,377 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,937 Previous Clinical Trials
13,198,780 Total Patients Enrolled
Janet E Hall, M.D.Principal InvestigatorMassachusetts General Hospital
10 Previous Clinical Trials
26,461 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby May 2025