Administration of Kisspeptin in Patients With Hyperprolactinemia

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Hypogonadism; Hyperprolactinemia

Treatments: Drug: GnRH; Drug: Kisspeptin 112-121

Study type: Interventional

Funder types: Other

Identifiers

NCT02956447

FD-R-5712 (Other Grant/Funding Number)

2016P002281

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Intravenous Kisspeptin

Experimental group

Description:

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).

Treatment:

Drug: Kisspeptin 112-121

Drug: GnRH

Subcutaneous Kisspeptin

Experimental group

Description:

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

Treatment:

Drug: Kisspeptin 112-121