Testosterone Regulation of the Natriuretic Peptide System

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 Overview

• Status: Withdrawn
• Conditions: Hypertension
• Intervention / Treatment: Drug: Testosterone; Drug: Nesiritide; Drug: Leuprolide; Drug: Anastrozole; Drug: Placebo

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Testosterone; Testosterone cream applied daily	Drug: Testosterone; Testosterone cream applied daily for two weeks; Drug: Nesiritide; Administered IV once during the study; Drug: Leuprolide; Administered twice during the study by injection; Drug: Anastrozole; Daily pill for 8 weeks
Placebo Comparator: Placebo; Identical placebo cream applied daily	Drug: Nesiritide; Administered IV once during the study; Drug: Leuprolide; Administered twice during the study by injection; Drug: Anastrozole; Daily pill for 8 weeks; Drug: Placebo; Inert cream otherwise identical to testosterone cream applied daily for two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Atrial natriuretic peptide levels	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Urinary salt excretion	8 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Karen K Miller, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Natriuretic Peptide
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Natriuretic Agents; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Androgens; Leuprolide; Testosterone; Anastrozole; Natriuretic Peptide, Brain
• Other Study ID Numbers: 2014P00