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Peptide Hormone

Subcutaneous Kisspeptin for Hypogonadotropic Hypogonadism

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

Congenital IHH confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial is looking for men & women with IHH. They will get a drug (Kisspeptin) under the skin and be monitored with ultrasounds & blood tests.

Who is the study for?

This trial is for men and women with idiopathic hypogonadotropic hypogonadism (IHH) who have low sex hormones due to low gonadotropins. Participants should not be on hormonal replacement or willing to stop it temporarily, and must have normal blood pressure. Pregnant women, those breastfeeding, or with a history of severe medication reactions cannot join.Check my eligibility

What is being tested?

The study tests if kisspeptin can trigger reproductive hormone release in IHH patients and help women ovulate. It involves subcutaneous injections of kisspeptin for two weeks and GnRH for about six days, along with ultrasound monitoring in women and frequent blood sampling to measure the body's response.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort at injection sites, possible allergic reactions to the hormones used, changes in reproductive hormone levels that could affect mood or physical symptoms like hot flashes or fatigue.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with congenital IHH based on hormone levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks 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

Secondary outcome measures

Percentage of female participants who demonstrate achievement of a mature follicle or show evidence of ovulation

Trial Design

1Treatment groups

Experimental Treatment

Group I: kisspeptin pumpExperimental Treatment2 Interventions

SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

kisspeptin 112-121

2013

Completed Phase 1

~120

GnRH

2017

Completed Phase 2

~320

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor

9 Previous Clinical Trials

1,304 Total Patients Enrolled

Stephanie SeminaraPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

24 Total Patients Enrolled

Stephanie Seminara, MDPrincipal InvestigatorMassachusetts General Hospital

5 Previous Clinical Trials

732 Total Patients Enrolled

Media Library

Kisspeptin 112-121 (Peptide Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT05896293 — Phase 2

Hypogonadotropic Hypogonadism Research Study Groups: kisspeptin pump

Hypogonadotropic Hypogonadism Clinical Trial 2023: Kisspeptin 112-121 Highlights & Side Effects. Trial Name: NCT05896293 — Phase 2

Kisspeptin 112-121 (Peptide Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05896293 — Phase 2

Frequently Asked Questions

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

Is this research endeavor currently open to participants?

"Absolutely, the evidence on clinicaltrials.gov implies that this trial is presently accepting applications. It was initially published on February 21st 2023 and has been revised as recently as May 31st 2023. 36 participants will be recruited from 1 location for the study."

Answered by AI

How does the administration of kisspeptin affect patient safety?

"The safety of the kisspeptin pump has been assessed as a 2 since this is currently in Phase 2 development. There are preliminary results that suggest it is secure, but no information yet to support its efficacy."

Answered by AI

What is the current enrollment size of this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that this research is proactively seeking recruitment, having been initially posted on February 21st 2023 and updated as recently as May 31st 2023. The study requires 36 participants from one medical centre to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Kisspeptin Administration Subcutaneously to Patients With IHH

Stephanie B. Seminara, MD 2023. "Kisspeptin Administration Subcutaneously to Patients With IHH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05896293.

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