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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

Study 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.Check my eligibility

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.See study design

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.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin

Secondary outcome measures

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

SGPT (ALT)

Hypoglycemia

Pneumonitis

Cardiovascular, other

100%

80%

60%

40%

20%

Study treatment Arm

All Participants

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

~320

kisspeptin 112-121

2013

Completed Phase 1

~120

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor

9 Previous Clinical Trials

1,316 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any additional investigations been conducted involving GnRH?

"As of the present day, 46 different medical trials are exploring GnRH. Of these, 10 have progressed to Phase 3 of clinical testing. Although Chicago is home to a majority of studies for this treatment, there exists 1,321 sites hosting various experiments related to it."

Answered by AI

Is GnRH a reliable option for medical treatment?

"According to Power's risk assessment scale, GnRH recieved a score of 2 due to the fact that there is some evidence indicating safety but no efficacy data available."

Answered by AI

Are there still vacancies available to join this clinical trial?

"Data hosted on clinicaltrials.gov affirms that this medical trial is presently accepting participants; the trial was initially posted on January 20, 2021 and was most recently updated June 29th 2022."

Answered by AI

How many participants have been enlisted for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial is currently accepting applicants with a first post date of January 20th 2021 and most recent edit on June 29th 2022. 24 individuals must be recruited from one site for this research endeavor to proceed as planned."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Stephanie B. Seminara, MD 2021. "Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04648969.

All > Hypogonadism