Administration of Kisspeptin in Patients With Hyperprolactinemia

The goal of this study is to learn more about how kisspeptin, a naturally occurring hormone, affects women with high levels of prolactin (also called hyperprolactinemia). Subjects in one group will undergo blood sampling every 10 minutes over two 12-hour periods (one 12-hour period without any intervention and one 12-hour period with intravenous (IV) kisspeptin administration). Subjects in the second group will receive subcutaneous (SC) kisspeptin every 90 minutes for eight days.

Study Overview

• Status: Completed
• Conditions: Hypogonadism; Hyperprolactinemia
• Intervention / Treatment: Drug: GnRH; Drug: Kisspeptin 112-121

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion/Exclusion Criteria:

• confirmed diagnosis of elevated levels of prolactin measured via blood test,
• no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
• no history of a medication reaction requiring emergency medical care,
• no illicit drug use or excessive alcohol consumption (>10 drinks/week),
• not currently seeking fertility, breastfeeding or pregnant,
• no history of bilateral oophorectomy,
• willing to complete a dopamine agonist washout and/or oral contraceptive washout,
• normal physical exam and laboratory studies within protocol reference range.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous Kisspeptin; Blood sampling every 10 minutes over two 12-hour periods. One 12-hour period without any intervention. One 12-hour period consisting of administration of 10 boluses of kisspeptin 112-121 intravenously (IV).	Drug: GnRH; 0.075 ug/kg IV; Other Names: gonadotropin-releasing hormone; Drug: Kisspeptin 112-121; 0.313 ug/kg - 2 ug/kg IV or SC; Other Names: Metastin 45-54
Experimental: Subcutaneous Kisspeptin; Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.	Drug: Kisspeptin 112-121; 0.313 ug/kg - 2 ug/kg IV or SC; Other Names: Metastin 45-54

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours	Average change in LH pulse frequency at baseline and during kisspeptin IV administration	Up to 14 days
Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin	Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration	Evaluated over eight days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change in LH Pulse Amplitude	Average change in LH pulse amplitude at baseline and during IV kisspeptin administration	Up to 14 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Stephanie Seminara, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): July 29, 2023

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimated): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Hypogonadism; Kisspeptin; GnRH; Hyperprolactinemia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Gonadal Disorders; Hypothalamic Diseases; Hyperpituitarism; Pituitary Diseases; Hypogonadism; Hyperprolactinemia; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 2016P002281; FD-R-5712 (Other Grant/Funding Number: FDA Office of Orphan Products Development)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After primary results are published, the authors will provide individual participant data upon request as long as it does not conflict with state or institutional regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No