Administration of Kisspeptin in Patients With Hyperprolactinemia

Massachusetts General Hospital36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperprolactinemia Hypogonadism

Interventions

Kisspeptin 112-121DRUG

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

GnRHDRUG

0.075 ug/kg IV

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Evaluated over eight days

Secondary Outcomes

Average Change in LH Pulse Amplitude

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

Time frame: Up to 14 days

Data from ClinicalTrials.gov

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