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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.