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NCT Number: 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

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.

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Key information

Conditions

Blood Pressure

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The New York Presbyterian Hospital-Weill Cornell Medical Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MENT or placebo

Drug

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).

Primary outcomes

  1. To assess the effects of MENT gel on blood pressure as compared to placebo gel.

    Time frame: 4 weeks

Secondary outcomes

  1. To evaluate the serum levels of MENT, testosterone, DHT, LH, FSH and estradiol and their variation under therapy

    Time frame: 4 weeks

  2. To assess the effects of MENT on sperm concentration

    Time frame: 21 months

  3. To evaluate the safety and tolerability of MENT.

    Time frame: 21 months

Sponsors and collaborators

Lead sponsor

Population Council

Other

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 22, 2008
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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