Hypogonadism Clinical Trial
Official title:
Administration of Kisspeptin in Patients With Hyperprolactinemia
Verified date | October 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 29, 2023 |
Est. primary completion date | June 28, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average change in number of luteinizing hormone (LH) pulse frequency (Kisspeptin Bolus and Baseline Sampling arm) | Average change in LH pulse frequency at baseline and during kisspeptin IV administration | Up to 23 days | |
Primary | Change in follicle size in mm by ultrasound (Pulsatile Kisspeptin arm) | Change in follicle size in mm by ultrasound over the course of SC kisspeptin administration | Evaluated over eight days | |
Secondary | Average change in LH pulse amplitude (Kisspeptin Bolus and Baseline Sampling arm) | Average change in LH pulse amplitude at baseline and during kisspeptin administration | Up to 23 days |
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