Testosterone Regulation of the Natriuretic Peptide System

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02269072

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Testosterone Drug: Nesiritide Drug: Leuprolide Drug: Anastrozole Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

Testosterone Regulation of the Natriuretic Peptide System

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Atrial natriuretic peptide levels [8 weeks]

Secondary Outcome Measures

Urinary salt excretion [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.