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Completed

NCT Number: NCT02956447

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.

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Key information

Conditions

Hyperprolactinemia Brain Diseases Central Nervous System Diseases Endocrine System Diseases Gonadal Disorders Hyperpituitarism Hypogonadism Hypothalamic Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kisspeptin 112-121

Drug

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

Other names: Metastin 45-54

GnRH

Drug

0.075 ug/kg IV

Other names: gonadotropin-releasing hormone

Primary outcomes

  1. Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours

    Time frame: Up to 14 days

    Average change in LH pulse frequency at baseline and during kisspeptin IV administration

  2. Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin

    Time frame: Evaluated over eight days

    Ultrasound evidence of increased follicle size over the course of SC kisspeptin administration

Secondary outcomes

  1. Average Change in LH Pulse Amplitude

    Time frame: Up to 14 days

    Average change in LH pulse amplitude at baseline and during IV kisspeptin administration

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2016
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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