Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

NCT ID: NCT04648969

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-03
• Study Completion Date: 2025-08-31

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.

Detailed Description

• Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure.
• Delivery of Interventions:

• Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.
• On the day of the inpatient study, the subjects will

• Undergo q10 min blood sampling for 6 hours,
• Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),
• Undergo q10 min blood samplings for another 6 hours,
• Receive a single GnRH IV bolus at hour 51.

Conditions

Hypogonadotropic Hypogonadism

Study Design

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

Study Groups

Experimental: kisspeptin, GnRH

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

Group Type: EXPERIMENTAL

kisspeptin 112-121

Intervention Type: DRUG

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

GnRH

Intervention Type: DRUG

1 intravenous dose of GnRH

Interventions

kisspeptin 112-121

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

Intervention Type: DRUG

GnRH

1 intravenous dose of GnRH

Intervention Type: DRUG

Other Intervention Names

metastin 45-54; gonadotropin-releasing hormone

Eligibility Criteria

Exclusion Criteria

• 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

• Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women,
• Men: on adequate testosterone replacement therapy: normal male reference range,
• Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated,
• For women,

• Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration),
• Not breastfeeding and not pregnant.

• 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; Massachusetts General Hospital; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephanie Seminara

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

313509

Identifier Type: -

Identifier Source: org_study_id