drugset / Trial / NCT02956447

Administration of Kisspeptin in Patients With Hyperprolactinemia

NCT02956447

Phase 2 Completed 36 enrolled Massachusetts General Hospital
Non-randomizedSequentialOpen-labelTreatment

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). 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.

Timeline

Start
2017-11-17
Primary completion
2023-06-28
Completion
2023-07-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonadorelin Protein / enzyme biologic 0.075 ug/kg Intravenous
Subject kisspeptin 112-121 Peptide 0.313 ug/kg Intravenous
Subject kisspeptin 112-121 Peptide 2 ug/kg Intravenous