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(PSC-0633) MENT Study


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A three-part trial assessing the effects of 7 alpha-methyl-19-nortestosterone (MENT) on blood pressure in normal men: an open-label pilot study, a nested pharmacokinetic study, followed by a randomized, double-blind, placebo-controlled study

Principal Investigator:
Peter Schlegel MD

Investigators:
Jeanne Walker ANP-C
Wayland Hsiao MD

Contact Information:
Clinical Research Support Office
Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: 1-800-RUCARES
Alt. Telephone: 1-800-782-2737
Email: RUCARES@Rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
Researchers are trying to develop a male birth control that stops the testes from making sperm. One drug being tested is a man-made hormone that is like testosterone, called MENT. MENT causes the body to make less sperm by decreasing the hormones your body needs to make sperm.

MENT is in a gel that gets applied to the abdomen. The drug is absorbed by the skin and travels into the bloodstream. In this study MENT gel will be compared to placebo gel. In an earlier study that treated men with MENT to lower sperm production, some men’s blood pressures went up. Blood pressures were still in the normal range, but this change needs to be studied further.

This is a three-part trial assessing the effects of MENT on blood pressure. The first and second parts of the trial will verify the MENT gel formulation delivers appropriate drug levels via an open-label pilot study and a subsequent open-label pharmacokinetics (PK) study. Part three, the main study, will follow to assess the effects of MENT on blood pressure in randomized, double-blind, and placebo-controlled design. Six men will be enrolled in the pilot study and six men will be enrolled in the intermediate PK study. Sixty-two men will be enrolled in the main study. All subjects will be enrolled at a single center.

In the open-label pilot study, subjects will receive MENT gel transdermally daily for four weeks and will have 24 hour blood pressure monitoring at baseline and at Week 4. In the PK study, subjects will apply MENT gel transdermally for two weeks and on Day 14 will have successive blood samples taken for MENT measurements. In the second part of the trial, subjects will apply MENT or placebo gel transdermally for 12 weeks and will have 24-hour ambulatory blood pressure monitoring (ABPM) at baseline, Week 6 and Week 12.

The ultimate goal is to develop a subdermal implant delivering MENT for long-term contraception.



Detailed Description of Protocol:
Profile:
Healthy men without known fertility problems.



What specifically makes a person eligible for the study?
You may be eligible to enter this study:

  • Healthy Male with No Known Fertility Problems
  • 18-40 Years Old
  • Do not smoke or use chewing tobacco, nicotine patch or nicotine gum


Gender:
Male

Age(s):
18-40

Children permitted to participate:
No

Potential Benefits.....
If you agree to take part in this study, there will be no direct medical benefits to you. Medical examinations and testing during this study may give you information about your general health. You will be able to consult with the study doctor and your own doctor about what findings mean and where to get additional healthcare if necessary.

We hope the information learned from this study will benefit other patients in the future. If researchers learn any new information that may affect your health, welfare or willingness to be a part of the study you will be informed by your study doctor in a timely manner.



Compensation:
Compensation is provided.