drugset / Trial / NCT01438073

Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

NCT01438073

Phase 1 Completed 96 enrolled Massachusetts General Hospital
NaSingle-groupOpen-labelOther

Summary

The investigators are looking for subjects to complete a study on the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the body to produce other reproductive hormones. However, giving someone a continued amount of kisspeptin over a period of time can have the opposite effect and tell the body to, for a short time, stop making hormones needed for reproduction. By giving 24-hour infusions of kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way bodies function normally and the role it has in conditions that affect the reproductive system.

Timeline

Start
2011-09
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonadorelin Protein / enzyme biologic 2.5 ng Intravenous
Subject Gonadorelin Protein / enzyme biologic 75 ng Intravenous
Subject Gonadorelin Protein / enzyme biologic 250 ng Intravenous
Subject kisspeptin 112-121 Peptide 0.313 ug/kg Intravenous
Subject kisspeptin 112-121 Peptide 12.5 ug/kg Intravenous
Subject kisspeptin 112-121 Peptide 13.19 ug/kg Intravenous
Subject kisspeptin 112-121 Peptide 40 ug/kg Intravenous