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

Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812630
• Other study ID #: Population Council #412
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2008
• Last updated: August 11, 2017
• Start date: December 2008
• Est. completion date: March 2014

Study information

• Verified date: August 2017
• Source: Population Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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).

Locations

Country	Name	City	State
United States	The New York Presbyterian Hospital-Weill Cornell Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Population Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effects of MENT gel on blood pressure as compared to placebo gel.		4 weeks
Secondary	To evaluate the serum levels of MENT, testosterone, DHT, LH, FSH and estradiol and their variation under therapy		4 weeks
Secondary	To assess the effects of MENT on sperm concentration		21 months
Secondary	To evaluate the safety and tolerability of MENT.		21 months