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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
Must not have
History of bilateral oophorectomy (ovaries were removed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had both of my ovaries removed.

Timeline

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

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

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: 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
leuprolide acetate
2005
Completed Phase 4
~6650
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
801 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
758 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
~21 spots leftby Jun 2027
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