Kisspeptin Administration Subcutaneously to Patients With IHH

NCT05896293 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FD007843
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Hypogonadotropic Hypogonadism

Keywords

Hypogonadotropic Hypogonadism; Kisspeptin; Idiopathic Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Average change in luteinizing hormone (LH) pulse amplitude

  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 Outcomes (1)

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

  2 weeks

Study Arms (1)

kisspeptin pump

EXPERIMENTAL

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; Drug: leuprolide acetate

Interventions

kisspeptin 112-121 DRUG

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

Also known as: metastin 45-54

kisspeptin pump

leuprolide acetate DRUG

Single SC bolus

kisspeptin pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Hypogonadism; Idiopathic Hypogonadotropic Hypogonadism

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Stephanie Seminara, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

617-726-1895; MGHKisspeptinResearch@partners.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: February 3, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)