Kisspeptin Administration Subcutaneously to Patients With IHH

NCT ID: NCT05896293

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2028-05-31

Brief Summary

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

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

Conditions

Hypogonadotropic Hypogonadism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

kisspeptin 112-121

Intervention Type: DRUG

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

leuprolide acetate

Intervention Type: DRUG

Single SC bolus

Interventions

kisspeptin 112-121

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

Intervention Type: DRUG

leuprolide acetate

Single SC bolus

Intervention Type: DRUG

Other Intervention Names

metastin 45-54

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stephanie B. Seminara, MD

OTHER

Sponsor Role: lead

Responsible Party

Stephanie B. Seminara, MD

Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephanie Seminara, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Coordinator

Role: CONTACT

MGHKisspeptinResearch@partners.org

617-726-1895

Facility Contacts

Study Coordinator

Role: primary

MGHKisspeptinResearch@partners.org

617-726-1895

Other Identifiers

FD007843

Identifier Type: -

Identifier Source: org_study_id