Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

NCT04648969 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 313509
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.

Conditions

Hypogonadotropic Hypogonadism

Keywords

hypogonadotropic hypogonadism, kisspeptin

Outcome Measures

Primary Outcomes (1)

• Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin

  Change in LH amplitude before, during and after kisspeptin administration

  52 hours

Secondary Outcomes (1)

• Average change in LH pulse frequency in response to kisspeptin

  52 hours

Study Arms (1)

Experimental: kisspeptin, GnRH

EXPERIMENTAL

• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.

Drug: kisspeptin 112-121; Drug: GnRH

Interventions

kisspeptin 112-121 DRUG

20 intravenous doses of kisspeptin 112-121 (4 different doses of kisspeptin (randomized) in 5 sets)

Also known as: metastin 45-54

Experimental: kisspeptin, GnRH

GnRH DRUG

1 intravenous dose of GnRH

Also known as: gonadotropin-releasing hormone

Experimental: kisspeptin, GnRH

Eligibility Criteria

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

You may not qualify if:

• Age 18 years and older,
• Confirmed diagnosis of HH with
• Low testosterone or estradiol,
• Low or low-normal gonadotropin levels,
• Thyroid stimulating hormone (TSH) and prolactin within the reference range,
• Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI),
• All other medical conditions stable and well controlled,
• No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition,
• No history of a medication reaction requiring emergency medical care,
• No illicit drug use,
• No excessive alcohol consumption (\<10 drinks/week),
• Normal blood pressure (BP), (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg),
• White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range,
• Prolactin below 110% of the upper limit of the reference range,
• Hemoglobin

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: December 2, 2020
• Study Start: May 3, 2019
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 18, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)