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
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Lamm, Steven, M.D.
ClinicalTrials.gov Identifier:
NCT00425568
First received: January 20, 2007
Last updated: January 22, 2007
Last verified: January 2007
  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 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
  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
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 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.
  More Information

No publications provided

ClinicalTrials.gov 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.:
hypogonadism
low testosterone level
gonadal deficiency

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014