Status:
COMPLETED
A Two-part Trial Assessing the Effects of 7α-methyl-19-nortestosterone (MENT) on Blood Pressure in Normal Men: an Open-label Pilot Study Followed by a Randomized, Double-blind, Placebo-controlled Study
Lead Sponsor:
Population Council
Conditions:
Blood Pressure
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
This is a two-part trial assessing the effects of MENT on blood pressure. The first part of the trial is an open-label pilot study to verify the MENT gel formulation delivers appropriate drug levels. ...
Eligibility Criteria
Inclusion
- Healthy men age 18-40
- Man has a sperm concentration of greater than or equal to 15 x 106/mL at screening
- Man has not used hormonal therapy in the last six months
- Man has a testosterone level between 270-1070 ng/dL at screening
Exclusion
- Man is hypertensive, defined by
- diastolic BP greater than or equal to 85 mmHg or systolic BP greater than or equal to 140 mmHg (the average of the 2nd and 3rd of 3 measurements after 10 minutes rest) at screening or
- a baseline ABPM average of diastolic greater than or equal to 85 mmHg systolic greater than or equal to 130 mmHg or
- is taking any hypertensive medication
- Man has a BMI over 33 kg/m2
- Man has active or a history of cerebrovascular or cardiovascular disease
- Man has chronic or acute liver or renal disease
- Man has a history of a significant psychiatric disorder, including severe depression
- Man has dermatitis, psoriasis or other severe skin disorder
- Man has clinically significant abnormalities of laboratory safety tests
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00812630
Start Date
December 1 2008
End Date
March 1 2014
Last Update
August 15 2017
Active Locations (1)
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1
The New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States, 10065