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Testosterone Regulation of the Natriuretic Peptide System

NCT ID: NCT02269072

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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Natriuretic Peptide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Testosterone

Testosterone cream applied daily

Group Type ACTIVE_COMPARATOR

Testosterone

Intervention Type DRUG

Testosterone cream applied daily for two weeks

Nesiritide

Intervention Type DRUG

Administered IV once during the study

Leuprolide

Intervention Type DRUG

Administered twice during the study by injection

Anastrozole

Intervention Type DRUG

Daily pill for 8 weeks

Placebo

Identical placebo cream applied daily

Group Type PLACEBO_COMPARATOR

Nesiritide

Intervention Type DRUG

Administered IV once during the study

Leuprolide

Intervention Type DRUG

Administered twice during the study by injection

Anastrozole

Intervention Type DRUG

Daily pill for 8 weeks

Placebo

Intervention Type DRUG

Inert cream otherwise identical to testosterone cream applied daily for two weeks

Interventions

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Testosterone

Testosterone cream applied daily for two weeks

Intervention Type DRUG

Nesiritide

Administered IV once during the study

Intervention Type DRUG

Leuprolide

Administered twice during the study by injection

Intervention Type DRUG

Anastrozole

Daily pill for 8 weeks

Intervention Type DRUG

Placebo

Inert cream otherwise identical to testosterone cream applied daily for two weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Klahr Miller, MD

Director, Neuroendocrine Research Program in Women's Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen K Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

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2014P00

Identifier Type: -

Identifier Source: org_study_id