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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Lamm, Steven, M.D..
Recruitment status was  Recruiting
Solvay Pharmaceuticals
Information provided by:
Lamm, Steven, M.D. Identifier:
First received: January 20, 2007
Last updated: January 22, 2007
Last verified: January 2007
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
Drug: AndroGel (Transdermal Testosterone Gel)
Phase 1

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
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:

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

Estimated Enrollment: 30
Study Start Date: December 2005

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00425568

Contact: Steven Lamm, M.D. 212-988-1146

United States, New York
Steven Lamm, M.D. Recruiting
New York, New York, United States, 10028
Contact: Steven Lamm, M.D.    212-988-1146   
Principal Investigator: Steven Lamm, M.D.         
Sponsors and Collaborators
Lamm, Steven, M.D.
Solvay Pharmaceuticals
Principal Investigator: Steven Lamm, M.D.
  More Information

No publications provided Identifier: NCT00425568     History of Changes
Other Study ID Numbers: DIR1-SLGSC 
Study First Received: January 20, 2007
Last Updated: January 22, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Lamm, Steven, M.D.:
low testosterone level
gonadal deficiency

Additional relevant MeSH terms:
Endocrine System Diseases
Gonadal Disorders
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 09, 2016