HypogonadismNCT00425568
Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR
An observational study of Hypogonadism, run by Lamm, Steven, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- What is being tested?
- AndroGel (Transdermal Testosterone Gel)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Testosterone <350 ng/dL,
- 21-59 years of age,
- BMI <30
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Transdermal Testosterone Gel and Its Effect on Erection Quality as Measured by a Digital Inflection Rigidometer (DIR)
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.
- Conditions
- Hypogonadism
- Being tested
- AndroGel (Transdermal Testosterone Gel)
- Keywords
- hypogonadism, low testosterone level, gonadal deficiency
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndroGel (Transdermal Testosterone Gel)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Lamm, Steven, M.D.
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Steven Lamm, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425568
- Sponsor's protocol ID
- DIR1-SLGSC
- Status last verified
- Dec 2007
- First submitted
- 20 Jan 2007
- Last updated
- 8 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Transdermal Testosterone Gel and Its Effect on Erection Quality as Measured by a Digital Inflection Rigidometer (DIR)
- ClinicalTrials.gov ID
- NCT00425568
- Acronym / sponsor ID
- DIR1-SLGSC
- Conditions
- Hypogonadism
- Keywords
- hypogonadism, low testosterone level, gonadal deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Lamm, Steven, M.D.
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Dec 2005
- First posted
- 23 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Testosterone <350 ng/dL,
- 21-59 years of age,
- BMI <30
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AndroGel (Transdermal Testosterone Gel) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Lamm, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism, run by Lamm, Steven, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.