Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Hypogonadotropic Hypogonadism Clinical Trial

Official title:

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648969
• Other study ID #: 313509
• Status: Recruiting
• Phase: Phase 2
• Start date: January 20, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: Study Coordinator
• Phone: 617-726-5384
• Email: MGHKisspeptinResearch[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion/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.

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism

Intervention

Drug:
• kisspeptin 112-121
20 intravenous doses of kisspeptin 112-121 (4 different doses of kisspeptin (randomized) in 5 sets)
• GnRH
1 intravenous dose of GnRH

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie B. Seminara, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average change in LH pulse frequency in response to kisspeptin	Change in LH frequency before and after kisspeptin administration	52 hours