Administration of Kisspeptin in Patients With Hyperprolactinemia

Purpose

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). All participants will receive kisspeptin in a pulsatile fashion. Subjects in one group will attend two 12-hour visits with frequent blood draws. Subjects in the second group will wear a pump that administers kisspeptin subcutaneously (SC) over eight days and attend seven short blood sampling visits.

Conditions

  • Hyperprolactinemia
  • Hypogonadism

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Kisspeptin Bolus and Baseline Sampling 		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 0.24 nmol/kg intravenously (IV) in a 10-hour period and one bolus of gonadotropin-releasing hormone (GnRH) at hour 11.
  • Drug: Kisspeptin 112-121
    0.313 ug/kg IV or 0.313 ug/kg - 13.19 ug/kg SC
    Other names:
    • Metastin 45-54
  • Drug: GnRH
    0.075 ug/kg IV
    Other names:
    • gonadotropin-releasing hormone
Experimental
Pulsatile Kisspeptin 		Subcutaneous (SC) administration of kisspeptin 112-121 0.24 nmol/kg IV every 90 minutes over eight days using a portable pump. One-time bolus of kisspeptin 112-121 2.4 nmol/kg IV (if necessary).
  • Drug: Kisspeptin 112-121
    0.313 ug/kg IV or 0.313 ug/kg - 13.19 ug/kg SC
    Other names:
    • Metastin 45-54

More Details

Status
Completed
Sponsor
Massachusetts General Hospital

Study Contact