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
Recruitment status was Recruiting
Sponsor:
Lamm, Steven, M.D.
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
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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 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:
Drug Information available for:
Testosterone propionate
Methyltestosterone
Testosterone cypionate
Testosterone
Testosterone enanthate
U.S. FDA Resources
Further study details as provided by Lamm, Steven, M.D.:
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. |
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 May 16, 2013