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

Population Council

Status and phase: Completed; Phase 1

Conditions: Blood Pressure

Treatments: Drug: MENT or placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00812630

Population Council #412

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

68 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Drug: MENT or placebo