Testosterone Regulation of the Natriuretic Peptide System

Mass General Brigham

Status: Withdrawn

Conditions: Hypertension

Treatments: Drug: Nesiritide; Drug: Placebo; Drug: Leuprolide; Drug: Anastrozole; Drug: Testosterone

Study type: Interventional

Funder types: Other

Identifiers

NCT02269072

2014P00

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Testosterone

Active Comparator group

Description:

Testosterone cream applied daily

Treatment:

Drug: Anastrozole

Drug: Nesiritide

Drug: Leuprolide

Drug: Testosterone

Placebo

Placebo Comparator group

Description:

Identical placebo cream applied daily

Treatment:

Drug: Anastrozole

Drug: Nesiritide

Drug: Leuprolide

Drug: Placebo