Clinical Trial: Administration of Kisspeptin in Patients With Hyperprolactinemia
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Administration of Kisspeptin in Patients With Hyperprolactinemia
Brief Summary: The goal of this project is to explore the use of exogenous pulsatile kisspeptin as a therapeutic alternative for patients with hyperprolactinemia who are intolerant to current therapies.
Detailed Summary:
Sponsor: Massachusetts General Hospital
Current Primary Outcome:
- Change in number of Luteinizing Hormone (LH) pulses between days 1 and 7 (Arms: Kisspeptin Bolus and Baseline) [ Time Frame: Evaluated at Visits 1 and 2 (Days 1 and 7) ]
- Change in follicle size in mm by ultrasound over the course of kisspeptin administration (Arm: Pulsatile Kisspeptin) [ Time Frame: Evaluated at Visits 10, 13, 15,17 (Days 7, 10, 12, and 14 kisspeptin administration) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Ovulation after high dose kisspeptin as evidenced by ultrasound (Arm: Pulsatile Kisspeptin) [ Time Frame: Evaluated on day 34 ]Ultrasound evidence of corpus luteum will be used to determine if ovulation occurred
- Prolactin [ Time Frame: Through study completion, an average of 3 months ]
- Follicle Stimulating Hormone (FSH) [ Time Frame: Through study completion, an average of 3 months ]
- Estrogen [ Time Frame: Through study completion, an average of 3 months ]
- Progesterone [ Time Frame: Through study completion, an average of 3 months ]
Original Secondary Outcome: Same as current
Information By: Massachusetts General Hospital
Dates:
Date Received: November 1, 2016
Date Started: March 2017
Date Completion: February 2021
Last Updated: February 2, 2017
Last Verified: February 2017
