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Peptide

Kisspeptin for Low Testosterone

Phase 2
Recruiting
Led By Stephanie Seminara
Research Sponsored by Stephanie B. Seminara, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years and older
Confirmed diagnosis of HH with low testosterone or estradiol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether using exogenous kisspeptin can help treat patients with HH by stimulating testosterone production.

Who is the study for?
Adults diagnosed with hypogonadotropic hypogonadism (HH) can join this trial if their condition is stable and they're not on meds affecting reproductive hormones, except for HH treatment. Women must not be pregnant or breastfeeding, and all participants need normal blood tests, hormone levels within certain ranges, no drug allergies needing emergency care, and no excessive alcohol use.
What is being tested?
The study is testing the effectiveness of kisspeptin 112-121 in treating low testosterone due to HH. It aims to develop new treatments by administering kisspeptin externally. Participants will receive either GnRH or kisspeptin as part of the trial interventions.
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, hormonal imbalances leading to mood changes or headaches, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with hypogonadotropic hypogonadism and have low testosterone or estradiol levels.
Select...
I have been diagnosed with HH and never had a severe reaction to medication.
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I have been diagnosed with Hemochromatosis and my other health conditions are stable.
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I have been diagnosed with HH and my prolactin levels are normal.
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I have HH and my kidney and liver tests are normal.
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I have been diagnosed with HH and my blood pressure is normal.
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I am not pregnant or breastfeeding.
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I have Hereditary Hemochromatosis with normal hemoglobin levels.
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I have HH with normal TSH and prolactin levels.
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My MRI shows no abnormal findings in my pituitary or hypothalamus, and I have been diagnosed with HH.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin
Secondary study objectives
Average change in LH pulse frequency in response to kisspeptin

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: kisspeptin, GnRHExperimental Treatment2 Interventions
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GnRH
2017
Completed Phase 2
~640
kisspeptin 112-121
2013
Completed Phase 1
~420

Find a Location

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor
9 Previous Clinical Trials
813 Total Patients Enrolled
Stephanie SeminaraPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Hypogonadotropic Hypogonadism Research Study Groups: Experimental: kisspeptin, GnRH
~2 spots leftby May 2025
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