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

NCT00812630 | Completed Phase 1

• 1 other identifier: Population Council #412
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure

Keywords

male hormonal contraception; Blood pressure, sperm concentration

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (3)

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

  4 weeks

• To assess the effects of MENT on sperm concentration

  21 months

• To evaluate the safety and tolerability of MENT.

  21 months

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

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).

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Council: lead

Study Sites (1)

The New York Presbyterian Hospital-Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

trestolone

Study Officials

• Regine Sitruk-Ware, MD

  Population Council

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: December 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 15, 2017

Record last verified: 2017-08

Locations

US (1)