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Neuropeptides in Human Reproduction

NCT01952782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-07-31

No results posted yet for this study

Summary

The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone.

We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.

Conditions

  • Hypogonadotropic Hypogonadism

Interventions

DRUG

Kisspeptin 112-121

Subjects will receive up to 10 IV doses of kisspeptin 112-121

DRUG

Naloxone

Subjects will receive one IV dose of naloxone followed by an IV infusion of naloxone.

DRUG

GnRH

Subjects will receive up to 10 doses of IV GnRH

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
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-05-31
Completion
2016-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01952782 on ClinicalTrials.gov