Primary or Secondary HypogonadismPhase 2NCT00193661
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism
A Phase 2 study testing Testosterone Gel (1%) in people with Primary or Secondary Hypogonadism and Constitutional Delay in Growth and Puberty (CDGP), run by Solvay Pharmaceuticals at 19 sites in United States.
Trial summary
This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E). Read more about this study
- Who is it for?
- Ages 13 to 17 years, men only
- Conditions the study is for
- Primary or Secondary Hypogonadism, Constitutional Delay in Growth and Puberty (CDGP)
- What is being tested?
- Testosterone Gel (1%)
- How many people
- Not given
- Where
- 19 sitesUnited States
- Study dates
- Aug 2002to Mar 2007
- Phase
- Phase 2
- 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 13 to 17 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)
Who cannot join
- Skin intolerance to alcohol or allergy to soy
- Generalized skin disease
- Contraindication to testosterone or androgen products
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Site 130
Birmingham, Alabama
Site 129
Brooklyn, New York
Site 131
Cincinnati, Ohio
Site 124
Columbus, Ohio
Site 121
Gainesville, Florida
Site 109
Hershey, Pennsylvania
Site 117
Indianapolis, Indiana
Site 127
Jacksonville, Florida
Site 128
Jacksonville, Florida
Site 111
Kansas City, Missouri
Site 107
Los Angeles, California
Site 104
Memphis, Tennessee
Site 123
New York, New York
Site 125
Philadelphia, Pennsylvania
Site 126
Philadelphia, Pennsylvania
Site 103
Portland, Oregon
Site 113
Sacramento, California
Site 205
Seattle, Washington
Site 114
Torrance, California
About this study
Official title: A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism
This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).
- Being tested
- Testosterone Gel (1%)
- Keywords
- Hypogonadism
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Gel (1%)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary or Secondary 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Unimed Pharmaceuticals
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193661
- Sponsor's protocol ID
- UMD-01-090
- Status last verified
- Sep 2006
- First submitted
- 11 Sep 2005
- Last updated
- 16 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism
- ClinicalTrials.gov ID
- NCT00193661
- Acronym / sponsor ID
- UMD-01-090
- Keywords
- Hypogonadism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Unimed Pharmaceuticals
- Study start
- Aug 2002
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 19 Sep 2005 (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.
This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)
Key exclusion criteria (3 listed)
- Skin intolerance to alcohol or allergy to soy
- Generalized skin disease
- Contraindication to testosterone or androgen products
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 |
|---|---|---|
| Testosterone Gel (1%) | 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 16 Jan 2015.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone Gel (1%) in people with Primary or Secondary Hypogonadism and Constitutional Delay in Growth and Puberty (CDGP), run by Solvay Pharmaceuticals at 19 sites 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 1 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 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 16 Jan 2015.