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Trial record 93 of 213 for:    "Hypogonadism" | "Androgens"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00425568
Recruitment Status : Completed
First Posted : January 23, 2007
Last Update Posted : August 8, 2018
Solvay Pharmaceuticals
Information provided by:
Lamm, Steven, M.D.

Brief 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.

Condition or disease Intervention/treatment
Hypogonadism Drug: AndroGel (Transdermal Testosterone Gel)

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Study Type : Observational
Enrollment : 30 participants
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)
Study Start Date : December 2005

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Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00425568

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United States, New York
Steven Lamm, M.D.
New York, New York, United States, 10028
Sponsors and Collaborators
Lamm, Steven, M.D.
Solvay Pharmaceuticals
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Principal Investigator: Steven Lamm, M.D.

Layout table for additonal information Identifier: NCT00425568     History of Changes
Other Study ID Numbers: DIR1-SLGSC
First Posted: January 23, 2007    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: December 2007
Keywords provided by Lamm, Steven, M.D.:
low testosterone level
gonadal deficiency
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents