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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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1st 7 days of treatment
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions

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
  • Olfacto-Genital Syndrome
  • Hypogonadotropic Hypogonadism

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ovulation
Secondary study objectives
pregnancy
Other study objectives
FSH
LH

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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
2,049 Previous Clinical Trials
2,730,875 Total Patients Enrolled
7 Trials studying Amenorrhea
1,470 Patients Enrolled for Amenorrhea
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,012 Total Patients Enrolled
7 Trials studying Amenorrhea
1,376 Patients Enrolled for Amenorrhea
Janet E Hall, M.D.Principal InvestigatorMassachusetts General Hospital
10 Previous Clinical Trials
26,461 Total Patients Enrolled
3 Trials studying Amenorrhea
1,230 Patients Enrolled for Amenorrhea
~7 spots leftby Nov 2025
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