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 - Full Text View

Sponsored by:	Population Council
Information provided by:	Population Council
ClinicalTrials.gov Identifier:	NCT00812630

Purpose

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.

Condition	Intervention	Phase
Blood Pressure	Drug: MENT or placebo	Phase I

Drug Information available for: Nandrolone Nandrolone decanoate Nandrolone phenpropionate Trestolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy 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

Further study details as provided by Population Council:

Primary Outcome Measures:

To assess the effects of MENT gel on blood pressure as compared to placebo gel. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the serum levels of MENT, testosterone, DHT, LH, FSH and estradiol and their variation under therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
To assess the effects of MENT on sperm concentration [ Time Frame: 21 months ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of MENT. [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	68
Study Start Date:	December 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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).

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812630

Contacts

Contact: Regine Sitruk-Ware, MD	212-327-7045	rsitrukware@popcouncil.org
Contact: Ruth Merkatz, RN	212-327-8647	rmerkatz@popcouncil.org

Locations

United States, New York
The New York Presbyterian Hospital-Weill Cornell Medical Center	Recruiting
New York, New York, United States, 10065
Contact: Peter Schlegel, MD
Principal Investigator: Peter Schlegel, MD

Sponsors and Collaborators

Population Council

Investigators

Study Director:

Regine Sitruk-Ware, MD

Population Council

More Information

Responsible Party:	Population Council ( Regine Sitruk-Ware, Study Coordinator )
Study ID Numbers:	Population Council #412
Study First Received:	December 18, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812630
Health Authority:	United States: Institutional Review Board

Keywords provided by Population Council:

male hormonal contraception
Blood pressure, sperm concentration

Study placed in the following topic categories:

Nandrolone
Nandrolone phenpropionate
Nandrolone decanoate
Spastic paraplegia epilepsy mental retardation
Trestolone

Additional relevant MeSH terms:

Anabolic Agents
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents
Contraceptives, Postcoital, Hormonal
Contraceptives, Postcoital
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 13, 2009