Clinical trial NCT00812630: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Blood Pressure
Keywords: male hormonal contraception
Blood pressure, sperm concentration
Lead sponsor: Population Council
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: To assess the effects of MENT gel on blood pressure as compared to placebo gel.
timeFrame: 4 weeks
Secondary outcomes:
measure: To evaluate the serum levels of MENT, testosterone, DHT, LH, FSH and estradiol and their variation under therapy
timeFrame: 4 weeks
measure: To assess the effects of MENT on sperm concentration
timeFrame: 21 months
measure: To evaluate the safety and tolerability of MENT.
timeFrame: 21 months
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Presbyterian Hospital-Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Population Council
name: Regine Sitruk-Ware, MD
role: STUDY_DIRECTOR
References: