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

Hypogonadism Clinical Trial

Official title:

Phase I Study of Transdermal Testosterone Gel and Its Effect on Erection Quality as Measured by a Digital Inflection Rigidometer (DIR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425568
• Other study ID #: DIR1-SLGSC
• Status: Completed
• Start date: December 2005

Study information

• Verified date: December 2007
• Source: Lamm, Steven, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• AndroGel (Transdermal Testosterone Gel)

Locations

Country	Name	City	State
United States	Steven Lamm, M.D.	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Lamm, Steven, M.D.	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States,