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). 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.
Conditions
- Hyperprolactinemia
- Hypogonadism
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Sex
- 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
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intravenous Kisspeptin |
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). |
|
|
Experimental Subcutaneous Kisspeptin |
Subcutaneous (SC) administration of kisspeptin 112-121 every 90 minutes over eight days. |
|
More Details
- Status
- Completed
- Sponsor
- Massachusetts General Hospital