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
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. Upon confirming MENT serum levels are within the required range, clinical trial material will be produced and labeled. Consequently, the second part of the trial, the main study, will proceed approximately two months after the conclusion of the pilot study. The main study, is a randomized, double-blind, placebo-controlled study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||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|
- To assess the effects of MENT gel on blood pressure as compared to placebo gel. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- To evaluate the serum levels of MENT, testosterone, DHT, LH, FSH and estradiol and their variation under therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- To assess the effects of MENT on sperm concentration [ Time Frame: 21 months ] [ Designated as safety issue: No ]
- To evaluate the safety and tolerability of MENT. [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
In the second part of the trial, subjects will apply MENT or placebo gel transdermally for 12 weeks and will have 24-hour blood pressure monitoring at baseline, Week 6 and Week 12.
Drug: MENT or placebo
A dose of 1600µg/d of MENT will be delivered daily using a gel formulation containing 8.0 mg of MENT per 1.0 mL (delivering 800µg/d). Two mLs of gel will be applied daily for four weeks in the pilot study (by 6 men) and for 12 weeks in the main trial (by 62 men).
|United States, New York|
|The New York Presbyterian Hospital-Weill Cornell Medical Center|
|New York, New York, United States, 10065|
|Study Director:||Regine Sitruk-Ware, MD||Population Council|