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Neuropeptides in Human Reproduction

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT01952782
Collaborator
(none)
128
Enrollment
1
Location
1
Arm
107
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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 GnRH and kisspeptin, 2 other naturally occurring reproductive hormones.

Condition or Disease Intervention/Treatment Phase
  • Drug: Kisspeptin 112-121
  • Drug: Naloxone
  • Drug: Gonadotropin Releasing Hormone (GnRH)
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Neuropeptides in Human Reproduction
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Naloxone, Kisspeptin, GnRH

The study will involve 3 visits: Outpatient screening visit Inpatient admission where subjects receive an intravenous infusion of naloxone, intravenous doses of kisspeptin 112-121, and intravenous doses of Gonadotropin Releasing Hormone (GnRH) Outpatient follow-up visit

Drug: Kisspeptin 112-121
Subjects will receive up to 10 intravenous doses of kisspeptin 112-121
Other Names:
  • Metastin 45-54

    • Drug: Naloxone
    Subjects will receive one intravenous dose of naloxone followed by an intravenous infusion of naloxone.

    Drug: Gonadotropin Releasing Hormone (GnRH)
    Subjects will receive up to 10 doses of intravenous Gonadotropin Releasing Hormone (GnRH)

    Outcome Measures

    Primary Outcome Measures

    1. Average difference in luteinizing hormone (LH) concentration before and after kisspeptin [Within 30 minutes of administration]

      Compares response to kisspeptin on and off naloxone infusion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Ages 21-40 (healthy men and regularly cycling women) OR ages 18-75 (men and women with hypogonadotropic hypogonadism (HH))

    • Normal blood pressure (systolic BP <140 mm Hg, diastolic BP <90 mm Hg)

    • White blood cell, platelets, prolactin, and thyroid stimulating hormone (TSH)within 90%-110% of laboratory reference range

    • Negative urine drug screen panel

    • Hemoglobin:

    1. For healthy men and healthy regularly cycling women: normal

    2. For men and women with HH: No less than 0.5 gm/dL below the lower limit of the reference range for normal women

    • Blood urea nitrogen (BUN), creatinine, liver function tests not elevated

    • For healthy subjects: Normal reproductive function and history

    • For healthy subjects: Body Mass Index (BMI) 18.5-30kg/m2

    • For subjects with HH: All medical conditions stable and well controlled

    Exclusion Criteria:

    • History of medication reaction requiring emergency medical attention

    • Illicit drug use

    • Consumption of more than 10 alcoholic drinks per week

    • Difficulty with blood draws

    • Currently seeking fertility, breastfeeding, or pregnant

    • For healthy subjects: history of chronic disease and prescription medication use (with the exception of seasonal allergy medication)

    • For subjects with HH: prescription medications known to affect reproductive endocrine function except for those used to treat the subject's reproductive condition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Stephanie B Seminara, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT01952782
    Other Study ID Numbers:
    • 2013P001543
    First Posted:
    Sep 30, 2013
    Last Update Posted:
    Jul 2, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypogonadism
    Naloxone
    Hormones

    Study Results

    No Results Posted as of Jul 2, 2021