A Phase 1 interventional study of MENT or placebo in Blood Pressure, sponsored by Population Council. Completed at 1 site in United States. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-15.
Sponsored by Population Council · Phase 1, Interventional, and Basic science
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.
Population Council is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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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).
To assess the effects of MENT gel on blood pressure as compared to placebo gel.
Time frame: 4 weeks
To evaluate the serum levels of MENT, testosterone, DHT, LH, FSH and estradiol and their variation under therapy
Time frame: 4 weeks
To assess the effects of MENT on sperm concentration
Time frame: 21 months
To evaluate the safety and tolerability of MENT.
Time frame: 21 months
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Population Council