Hypertension
Conditions
Keywords
Natriuretic Peptide
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.
Interventions
DRUGTestosterone
Testosterone cream applied daily for two weeks
DRUGNesiritide
Administered IV once during the study
DRUGLeuprolide
Administered twice during the study by injection
DRUGAnastrozole
Daily pill for 8 weeks
DRUGPlacebo
Inert cream otherwise identical to testosterone cream applied daily for two weeks
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial natriuretic peptide levels | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Urinary salt excretion | 8 weeks |
Outcome results
None listed