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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02956447
Other study ID # 2016P002281
Secondary ID FD-R-5712
Status Completed
Phase Phase 2
First received
Last updated
Start date November 17, 2017
Est. completion date July 29, 2023

Study information

Verified date October 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Kisspeptin 112-121
0.313 ug/kg IV or 0.313 ug/kg - 13.19 ug/kg SC
GnRH
0.075 ug/kg IV

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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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