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NCT02269072 Clinical Trial

Testosterone Regulation of the Natriuretic Peptide System

Hypertension Clinical Trial

Official title:
Testosterone Regulation of the Natriuretic Peptide System

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02269072
Other study ID # 2014P00
Secondary ID
Status Withdrawn
Phase N/A
First received October 15, 2014
Last updated October 17, 2017
Start date February 2015
Est. completion date February 2016

Study information
Verified date October 2017
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Testosterone
Testosterone cream applied daily for two weeks
• Nesiritide
Administered IV once during the study
• Leuprolide
Administered twice during the study by injection
• Anastrozole
Daily pill for 8 weeks
• Placebo
Inert cream otherwise identical to testosterone cream applied daily for two weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Atrial natriuretic peptide levels 8 weeks
Secondary Urinary salt excretion 8 weeks
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