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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Population Council
ClinicalTrials.gov Identifier:
NCT00812630
First received: December 18, 2008
Last updated: March 15, 2012
Last verified: March 2012
History of Changes

December 18, 2008
March 15, 2012
December 2008
June 2012   (final data collection date for primary outcome measure)
To assess the effects of MENT gel on blood pressure as compared to placebo gel. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00812630 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Blood Pressure
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).
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.
Intervention: Drug: MENT or placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
68
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00812630
Population Council #412
No
Population Council
Population Council
Not Provided
Study Director: Regine Sitruk-Ware, MD Population Council
Population Council
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP