Administration of Kisspeptin in Patients With Hyperprolactinemia

Phase 2

Completed

• Conditions: Hypogonadism; Hyperprolactinemia
• Interventions: Drug: Kisspeptin 112-121; Drug: GnRH

• Registration Number: NCT02956447
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Study Start: 2017-11-17
• Primary Completion: 2023-06-28
• Study Completion: 2023-07-29
• Results First Submitted: 2024-06-28
• Results First Submitted QC: 2024-07-30
• Results First Posted: 2024-08-20
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-16
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intravenous Kisspeptin	Kisspeptin 112-121	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).
Intravenous Kisspeptin	GnRH	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).
Subcutaneous Kisspeptin	Kisspeptin 112-121	Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average Change in LH Pulse Amplitude	Up to 14 days	Average change in LH pulse amplitude at baseline and during IV kisspeptin administration

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States