Administration of Kisspeptin in Patients With Hyperprolactinemia

NCT02956447 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2016P002281FD-R-5712
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperprolactinemia; Hypogonadism

Keywords

Kisspeptin; Hyperprolactinemia; GnRH; Hypogonadism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Average Change in LH Pulse Amplitude

  Up to 14 days

Study Arms (2)

Intravenous Kisspeptin

EXPERIMENTAL

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: Kisspeptin 112-121; Drug: GnRH

Subcutaneous Kisspeptin

EXPERIMENTAL

Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days.

Drug: Kisspeptin 112-121

Interventions

Kisspeptin 112-121 DRUG

0.313 ug/kg - 2 ug/kg IV or SC

Also known as: Metastin 45-54

Intravenous Kisspeptin; Subcutaneous Kisspeptin

GnRH DRUG

0.075 ug/kg IV

Also known as: gonadotropin-releasing hormone

Intravenous Kisspeptin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hyperprolactinemia; Hypogonadism

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Gonadal Disorders

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

Results Point of Contact

• Title: Dr. Stephanie Seminara
• Organization: Massachusetts General Hospital

MGHKisspeptinResearch@partners.org

617-724-5390

Study Officials

• Stephanie Seminara, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 7, 2016
• Study Start: November 17, 2017
• Primary Completion: June 28, 2023
• Study Completion: July 29, 2023
• Last Updated: October 1, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)