Administration of Kisspeptin in Patients With Hyperprolactinemia

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this project is to explore the use of exogenous pulsatile kisspeptin as a therapeutic alternative for patients with hyperprolactinemia who are intolerant to current therapies.

Funding Source - FDA OOPD

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Hormones

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.