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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Blood Pressure

Intervention / Treatment
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* Drug: MENT or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects of MENT gel on blood pressure as compared to placebo gel. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the serum levels of MENT, testosterone, DHT, LH, FSH and estradiol and their variation under therapy |  | 4 weeks | 
| To assess the effects of MENT on sperm concentration |  | 21 months | 
| To evaluate the safety and tolerability of MENT. |  | 21 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male hormonal contraception, Blood pressure, sperm concentration