Administration of Kisspeptin in Patients With Hyperprolactinemia

Study Overview
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Brief Summary
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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.

Official Title
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Administration of Kisspeptin in Patients With Hyperprolactinemia

Conditions
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Hyperprolactinemia, Hypogonadism

Intervention / Treatment
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* Drug: Kisspeptin 112-121
* Drug: GnRH


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kisspeptin Bolus and Baseline Sampling<br>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<br>* 0.313 ug/kg IV or 0.313 ug/kg - 13.19 ug/kg SC<br>* Other names: Metastin 45-54;Drug: GnRH<br>* 0.075 ug/kg IV<br>* Other names: gonadotropin-releasing hormone;|
| Experimental: Pulsatile Kisspeptin<br>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<br>* 0.313 ug/kg IV or 0.313 ug/kg - 13.19 ug/kg SC<br>* Other names: Metastin 45-54;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperprolactinemia, GnRH, Hypogonadism, Kisspeptin