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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
  Purpose

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.


Condition Intervention Phase
Blood Pressure
 Drug: MENT or placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Population Council:

Primary Outcome Measures:
  • To assess the effects of MENT gel on blood pressure as compared to placebo gel. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 68
Study Start Date: December 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812630

Locations
United States, New York
The New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States, 10065
Sponsors and Collaborators
Population Council
Investigators
Study Director: Regine Sitruk-Ware, MD Population Council
  More Information

No publications provided

Responsible Party: Population Council
ClinicalTrials.gov Identifier: NCT00812630     History of Changes
Other Study ID Numbers: Population Council #412
Study First Received: December 18, 2008
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Population Council:
male hormonal contraception
Blood pressure, sperm concentration

Additional relevant MeSH terms:
Nandrolone
Nandrolone decanoate
Nandrolone phenpropionate
Trestolone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Anabolic Agents
Contraceptives, Postcoital, Hormonal
Contraceptives, Postcoital
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013