Testosterone Regulation of the Natriuretic Peptide System
Not Applicable
Withdrawn
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT02269072
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Testosterone Testosterone Testosterone cream applied daily Placebo Anastrozole Identical placebo cream applied daily Placebo Placebo Identical placebo cream applied daily Testosterone Leuprolide Testosterone cream applied daily Testosterone Nesiritide Testosterone cream applied daily Testosterone Anastrozole Testosterone cream applied daily Placebo Leuprolide Identical placebo cream applied daily Placebo Nesiritide Identical placebo cream applied daily
- Primary Outcome Measures
Name Time Method Atrial natriuretic peptide levels 8 weeks
- Secondary Outcome Measures
Name Time Method Urinary salt excretion 8 weeks