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Testosterone Regulation of the Natriuretic Peptide System

Primary Purpose

Hypertension

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Testosterone
Nesiritide
Leuprolide
Anastrozole
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring Natriuretic Peptide

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men: aged 18 to 40 years, normal testosterone and free testosterone levels, no history of hypertension, and BMI between 18.5 and 25.
  • Women: aged 18 to 40 years old, regular menstrual periods, negative pregnancy test, no oral contraceptives for ≥ 3 mos, no history of hypertension, BMI between 18.5 and 25.

Exclusion Criteria:

  • Antihypertensives, diuretics or insulin, diabetes mellitus, prior cardiovascular, abnormal liver or renal disease, history of cancer, atrial fibrillation, or abnormal sodium or potassium level.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Testosterone

    Placebo

    Arm Description

    Testosterone cream applied daily

    Identical placebo cream applied daily

    Outcomes

    Primary Outcome Measures

    Atrial natriuretic peptide levels

    Secondary Outcome Measures

    Urinary salt excretion

    Full Information

    First Posted
    October 15, 2014
    Last Updated
    October 17, 2017
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02269072
    Brief Title
    Testosterone Regulation of the Natriuretic Peptide System
    Official Title
    Testosterone Regulation of the Natriuretic Peptide System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funding
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The proposed study is a physiologic investigation of the effects of testosterone on the natriuretic peptide system. The hypotheses of the study are that testosterone administration will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks in duration.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    Natriuretic Peptide

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Testosterone
    Arm Type
    Active Comparator
    Arm Description
    Testosterone cream applied daily
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Identical placebo cream applied daily
    Intervention Type
    Drug
    Intervention Name(s)
    Testosterone
    Intervention Description
    Testosterone cream applied daily for two weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Nesiritide
    Intervention Description
    Administered IV once during the study
    Intervention Type
    Drug
    Intervention Name(s)
    Leuprolide
    Intervention Description
    Administered twice during the study by injection
    Intervention Type
    Drug
    Intervention Name(s)
    Anastrozole
    Intervention Description
    Daily pill for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Inert cream otherwise identical to testosterone cream applied daily for two weeks
    Primary Outcome Measure Information:
    Title
    Atrial natriuretic peptide levels
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Urinary salt excretion
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Men: aged 18 to 40 years, normal testosterone and free testosterone levels, no history of hypertension, and BMI between 18.5 and 25. Women: aged 18 to 40 years old, regular menstrual periods, negative pregnancy test, no oral contraceptives for ≥ 3 mos, no history of hypertension, BMI between 18.5 and 25. Exclusion Criteria: Antihypertensives, diuretics or insulin, diabetes mellitus, prior cardiovascular, abnormal liver or renal disease, history of cancer, atrial fibrillation, or abnormal sodium or potassium level.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karen K Miller, MD
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Testosterone Regulation of the Natriuretic Peptide System

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