A Phase 1 interventional study of Testerone Transdermal System in Hypogonadism, sponsored by Watson Pharmaceuticals. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-05.
Sponsored by Watson Pharmaceuticals · Phase 1, Interventional, and Treatment
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
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.
345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.
This study's enrollment of 40 is below the median of 56 across 260 interventional studies indexed under Hypogonadism.
Browse Hypogonadism studies →Watson Pharmaceuticals is the lead sponsor of 30 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Testosterone
Drug: Testerone Transdermal System
Transdermal testosterone applied daily for 4 weeks
Also known as: Testosterone
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.
Time frame: Day 28/29
| Milestone | Testosterone Transdermal Systems |
|---|---|
| Started | 40 |
| Baseline characteristics measured | 35 |
| Completed | 35 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Did not meet inclusion criteria | 4 |
A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.
| ng/dL | Testosterone Transdermal Systems |
|---|---|
| Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours | 463 ± 122.1 |
Collected over 28 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Testosterone Transdermal Systems | — | 0/40 (0%) | 9/40 (22.5%) |
| Event | Testosterone Transdermal Systems |
|---|---|
| Application site pruritusSkin and subcutaneous tissue disorders | 6/40 |
| Application site vesiclesSkin and subcutaneous tissue disorders | 2/40 |
| Back PainMusculoskeletal and connective tissue disorders | 2/40 |
| Age, Categorical(Participants) | Testosterone Transdermal Systems |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 32 |
| >=65 years | 3 |
| Age Continuous(years) | Testosterone Transdermal Systems |
|---|---|
| Mean | 55.1 ± 8.70 |
| Sex: Female, Male(Participants) | Testosterone Transdermal Systems |
|---|---|
| Female | 0 |
| Male | 35 |
| Region of Enrollment(participants) | Testosterone Transdermal Systems |
|---|---|
| United States | 35 |
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Watson Pharmaceuticals