At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 256 enrolled
Drug / intervention
kisspeptin 112-121 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Administration of Kisspeptin to Subjects With Reproductive Disorders
In Brief
A Phase 1 clinical trial evaluating kisspeptin 112-121 and GnRH for Hypogonadotropic Hypogonadism and 5 related conditions. Completed, enrolled 256 participants across 1 site.
Detailed Summary
The goal of this study is to learn about the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadotropic Hypogonadism, Kallmann Syndrome, GnRH Deficiency, PCOS, Polycystic Ovarian Syndrome, Hyperprolactinemia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartJun 2009
Primary CompletionOct 2021
TodayJul 2026
First PostedJun 5, 2009
Enrollment StartJun 23, 2009
Primary CompletionOct 22, 2021
TodayJul 2, 2026
Enrollment to primary: 12.3 yearsPosted 17.1 years ago
Interventions
kisspeptin 112-121drug
One or more IV or SC doses of kisspeptin 112-121, and/or short infusion (up to 12 hours) of kisspeptin 112-121
GnRHdrug
One or more IV doses of GnRH, and/or SC administration of GnRH