Testosterone Regulation of the Natriuretic Peptide System

Massachusetts General Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Conditions

Hypertension

Interventions

TestosteroneDRUG

Testosterone cream applied daily for two weeks

NesiritideDRUG

Administered IV once during the study

LeuprolideDRUG

Administered twice during the study by injection

Anastrozole

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Atrial natriuretic peptide levels

Time frame: 8 weeks

Secondary Outcomes

Urinary salt excretion

Time frame: 8 weeks

Data from ClinicalTrials.gov

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