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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
Hypogonadism Drug: AndroGel (Transdermal Testosterone Gel) Phase 1

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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   (Adult)
Sexes 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 Identifier: NCT00425568     History of Changes
Other Study ID Numbers: DIR1-SLGSC
Study First Received: January 20, 2007
Last Updated: January 22, 2007

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

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on September 19, 2017