HypogonadismPhase 1NCT01104246
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
A Phase 1 study testing Testerone Transdermal System in people with Hypogonadism, run by Watson Pharmaceuticals at 3 sites in United States.
Trial summary
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testerone Transdermal System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2010to Sep 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males in good general health, 18 years of age or older.
- Have a previously documented testosterone deficiency.
- Willing and able to comply with the requirements of the protocol.
Who cannot join
- Have a history of intolerance to Androderm or other testosterone products.
- Prostate specific antigen (PSA) level ≥ 4.0 ng/mL
- Prostate cancer or severe benign prostatic hypertrophy (BPH)
- Have significant abnormalities in the physical examination at screening.
- Have current dermatological disease, skin damage or blemishes.
- Have participated in an investigational drug study within 30 days prior to screening.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Watson investigational site
Miramar, Florida, 33025
Watson investigational site
Omaha, Nebraska, 68184
Watson investigational site
San Antonio, Texas, 78209
About this study
Official title: An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
Read the detailed description
Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.
- Conditions
- Hypogonadism
- Being tested
- Testerone Transdermal System
- Keywords
- Hypogonadism, Testosterone, Hormone replacement therapy
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testerone Transdermal SystemDrug
Also called Testosterone
Transdermal testosterone applied daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Testosterone Transdermal Systems | Experimental | Testosterone Receives: Drug: Testerone Transdermal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.
Measured: Day 28/29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keshava Kumar, PhD, MHSA, Study director, Watson Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104246
- Sponsor's protocol ID
- AND1001
- Status last verified
- Oct 2012
- First submitted
- 13 Apr 2010
- Last updated
- 5 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT01104246
- Acronym / sponsor ID
- AND1001
- Conditions
- Hypogonadism
- Keywords
- Hypogonadism, Testosterone, Hormone replacement therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Posted 23 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
Detailed description
Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosterone Transdermal Systems | Experimental | Drug: Testerone Transdermal SystemTestosterone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males in good general health, 18 years of age or older.
- Have a previously documented testosterone deficiency.
- Willing and able to comply with the requirements of the protocol.
Key exclusion criteria (6 listed)
- Have a history of intolerance to Androderm or other testosterone products.
- Prostate specific antigen (PSA) level ≥ 4.0 ng/mL
- Prostate cancer or severe benign prostatic hypertrophy (BPH)
- Have significant abnormalities in the physical examination at screening.
- Have current dermatological disease, skin damage or blemishes.
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 |
|---|---|---|
| Testerone Transdermal SystemAlso: TestosteroneTransdermal testosterone applied daily for 4 weeks | Drug | Testosterone Transdermal Systems |
Primary outcome
Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
Time frame: Day 28/29
A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Keshava Kumar, PhD, MHSA study director
Watson Laboratories
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Testerone Transdermal System in people with Hypogonadism, run by Watson Pharmaceuticals at 3 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 3 inclusion and 6 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 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours (time frame: Day 28/29). It is what the study was designed to measure, not a finding.
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 5 Oct 2012.