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Hormone Therapy

GnRH for Hypogonadism

Phase 1
Waitlist Available
Led By Stephanie B Seminara, MD
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

This trial is testing the effects of continued exposure to the hormone kisspeptin on the human reproductive system.

Eligible Conditions
  • Hypogonadism
  • Healthy Postmenopausal Women
  • Hypogonadotropic Hypogonadism

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion
Secondary outcome measures
Average difference in estradiol concentration at the beginning and end of kisspeptin infusion (females)
Average difference in testosterone concentration at the beginning and end of kisspeptin infusion (males)

Side effects data

From 2009 Phase 2 trial • 36 Patients • NCT00586898
22%
Hyperglycemia
19%
Hot Flashes
17%
Dyspnea
14%
Hyperkalemia
8%
SGPT (ALT)
6%
Hypoglycemia
3%
Pneumonitis
3%
Cardiovascular, other
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants

Trial Design

1Treatment groups
Experimental Treatment
Group I: kisspeptin, GnRHExperimental Treatment2 Interventions
24-hour continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg), and single bolus of GnRH (gonadotropin-releasing hormone) (2.5-250 ng/kg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GnRH
2017
Completed Phase 2
~320
kisspeptin 112-121
2013
Completed Phase 1
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,385 Total Patients Enrolled
15 Trials studying Hypogonadism
7,093 Patients Enrolled for Hypogonadism
Stephanie B Seminara, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
5,510 Total Patients Enrolled
6 Trials studying Hypogonadism
5,364 Patients Enrolled for Hypogonadism

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
Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling
Stephanie B. Seminara, MD 2011. "Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01438073.
~7 spots leftby Apr 2025
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