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Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

NCT01438073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-07-11

No results posted yet for this study

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.

Conditions

  • Hypogonadotropic Hypogonadism
  • Healthy Postmenopausal Women
  • Agonadism

Interventions

DRUG

kisspeptin 112-121

24-h continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg)

DRUG

GnRH

Single intravenous dose of GnRH (2.5-250 ng/kg)

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Stephanie B Seminara, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-04-30
Completion
2016-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01438073 on ClinicalTrials.gov