Kisspeptin Administration Subcutaneously to Patients With IHH

September 30, 2025 updated by: Stephanie B. Seminara, MD

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.

Funding Source: FDA OOPD

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions:

  • Each subject will undergo a review of their medical history, physical exam, and screening laboratories.
  • A single SC injection of leuprolide acetate may be administered approximately six days before kisspeptin administration. (Previously administration of Gonadotropin Releasing Hormone (GnRH) was used in this study.)
  • A pelvic ultrasound will be performed on women to assess baseline follicular size.
  • A pump will be placed to administer pulsatile SC kisspeptin for two weeks.

  • During the course of kisspeptin administration, subjects will

    • Undergo q10 min blood sampling (approximately 10 sessions, 70 minutes each)
    • For women, undergo pelvic ultrasounds (approximately 4 sessions)
  • Optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Congenital IHH

    o Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins

  • Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
  • No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration

Exclusion Criteria:

  • Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol

  • Excessive alcohol consumption (>10 drinks/week) and/or active use of illicit drugs

    o Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation.

  • Pregnant or trying to become pregnant
  • Breast feeding
  • History of: bilateral oophorectomy (both ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kisspeptin pump
SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes); administration of a single shot of leuprolide acetate (previously GnRH was used in this study)
Drug: kisspeptin 112-121
SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)
Other Names:
  • metastin 45-54
Drug: leuprolide acetate
Single SC bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average change in luteinizing hormone (LH) pulse amplitude
Time Frame: 2 weeks
Average difference in LH amplitude after the first dose of kisspeptin (day 1) compared to the last dose of kisspeptin (day 15)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of female participants who demonstrate achievement of a mature follicle or show evidence of ovulation
Time Frame: 2 weeks
Percentage of female participants that develop a mature follicle or ovulate. Mature follicle achievement is defined as evidence of a follicle with maximum diameter ≥18 mm. Evidence of ovulation is defined as detection of a corpus luteum on ultrasound in combination with elevated progesterone level.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephanie B. Seminara, MD

Investigators

  • Principal Investigator: Stephanie Seminara, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FD007843

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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