Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR

This study is currently recruiting participants.

Verified by Lamm, Steven, M.D., January 2007

First Received: January 20, 2007 Last Updated: January 22, 2007 History of Changes

Sponsor:	Lamm, Steven, M.D.
Collaborator:	Solvay Pharmaceuticals
Information provided by:	Lamm, Steven, M.D.
ClinicalTrials.gov Identifier:	NCT00425568

Purpose

Low testosterone may be responsible for "soft" erections in men. The purpose of our study is to see whether the daily application of a testosterone gel to raise testosterone levels will also increase the "hardness" of a man's erection.

Condition	Intervention	Phase
Hypogonadism	Drug: AndroGel (Transdermal Testosterone Gel)	Phase I

Study Type:	Observational
Study Design:	Cross-Sectional, Defined Population, Prospective Study
Official Title:	Phase I Study of Transdermal Testosterone Gel and Its Effect on Erection Quality as Measured by a Digital Inflection Rigidometer (DIR)

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Lamm, Steven, M.D.:

Estimated Enrollment:	30
Study Start Date:	December 2005

Eligibility

Ages Eligible for Study:	21 Years to 59 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Testosterone <350 ng/dL,
21-59 years of age,
BMI <30

Exclusion Criteria:

Those with carcinoma of the breast or known or suspected carcinoma of the prostate or with known hypersensitivity to any of the ingredients in AndroGel.
Men will be excluded if they have unstable angina, hypertension, diabetes, heart failure, or coronary artery disease.
Men will agree to discontinue use of current testosterone replacement, as well as Viagra or any other PDE5 inhibitors for 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425568

Contacts

Contact: Steven Lamm, M.D.

212-988-1146

slamm10@gmail.com

Locations

United States, New York
Steven Lamm, M.D.	Recruiting
New York, New York, United States, 10028
Contact: Steven Lamm, M.D. 212-988-1146 slamm10@gmail.com
Principal Investigator: Steven Lamm, M.D.

Sponsors and Collaborators

Lamm, Steven, M.D.

Solvay Pharmaceuticals

Investigators

Principal Investigator:

Steven Lamm, M.D.

Unaffiliated

More Information

No publications provided

Study ID Numbers:	DIR1-SLGSC
Study First Received:	January 20, 2007
Last Updated:	January 22, 2007
ClinicalTrials.gov Identifier:	NCT00425568 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Lamm, Steven, M.D.:

hypogonadism
low testosterone level
gonadal deficiency

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on February 08, 2010