- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00812630
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
August 11, 2017 updated by: Population Council
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 Overview
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- The New York Presbyterian Hospital-Weill Cornell Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To assess the effects of MENT gel on blood pressure as compared to placebo gel.
Time Frame: 4 weeks
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the serum levels of MENT, testosterone, DHT, LH, FSH and estradiol and their variation under therapy
Time Frame: 4 weeks
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4 weeks
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To assess the effects of MENT on sperm concentration
Time Frame: 21 months
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21 months
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To evaluate the safety and tolerability of MENT.
Time Frame: 21 months
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21 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Regine Sitruk-Ware, MD, Population Council
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
December 18, 2008
First Submitted That Met QC Criteria
December 19, 2008
First Posted (Estimate)
December 22, 2008
Study Record Updates
Last Update Posted (Actual)
August 15, 2017
Last Update Submitted That Met QC Criteria
August 11, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- Population Council #412
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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