CompletedPhase 2

Administration of Kisspeptin in Patients With Hyperprolactinemia

United States36 participantsStarted 2017-11-17

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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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.

What they're measuring

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

Timeframe: Up to 14 days

Number of Participants With Evidence of Follicle Growth From Subcutaneous Kisspeptin

Timeframe: Evaluated over eight days

Trial details

NCT IDNCT02956447

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-28

Results submitted2024-06-28

View on ClinicalTrials.gov More Hyperprolactinemia trials