← Back to Search

Hormone Therapy

Pulsatile GnRH for Amenorrhea

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
Women and minors with GnRH deficiency or idiopathic hypogonadotropic hypogonadism (IHH) will have a history of primary amenorrhea, no evidence of abnormalities in other hormonal axes, a deficient pattern of luteinizing hormone (LH) and/or free alpha subunit (FAS) secretion on baseline sampling and a normal cranial CT or MRI.
Women and minors with hypothalamic amenorrhea will have a history of secondary amenorrhea of at least six months duration with low or normal gonadotropins or a history of primary amenorrhea in the presence of pulsatile patterns of LH or FAS on baseline frequent sampling studies, BMI > 18 kg/m2 and normal testosterone and prolactin levels.
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
  • Amenorrhea
  • Hypogonadotropic Hypogonadism
  • Olfacto-Genital Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
1,952 Previous Clinical Trials
2,660,561 Total Patients Enrolled
7 Trials studying Amenorrhea
1,470 Patients Enrolled for Amenorrhea
Massachusetts General HospitalLead Sponsor
2,922 Previous Clinical Trials
13,193,260 Total Patients Enrolled
6 Trials studying Amenorrhea
1,262 Patients Enrolled for Amenorrhea
Janet E Hall, M.D.Principal InvestigatorMassachusetts General Hospital
10 Previous Clinical Trials
21,461 Total Patients Enrolled
3 Trials studying Amenorrhea
1,230 Patients Enrolled for Amenorrhea

Frequently Asked Questions

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