HealthyPhase 1NCT00791856
Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch
A Phase 1 study testing testosterone in people with Healthy, run by Warner Chilcott at 4 sites in United States.
Trial summary
This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy (i.e., estrogen for surgically postmenopausal women or a continuous regimen of estrogen plus progestin for naturally postmenopausal… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- testosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2007to May 2008
- Phase
- Phase 1
- 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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be a surgically postmenopausal female between 20 and 70 years of age who had a hysterectomy and bilateral oophorectomy at least 6 months prior to screening, or be a healthy naturally postmenopausal female between 50 and 70 years of age who had experienced amenorrhea for at least 12 months prior to screening;
- be in good general health based on medical history, physical examination, and laboratory evaluation;
- have had a mammogram, with no clinically significant abnormalities, within the preceding 12 months in subjects > 40 years of age;
- be on a stable dose of approved hormone therapy restricted to oral or transdermal regimens (vaginal products are not acceptable) for a period of at least 12 weeks prior to screening:
- estrogen only for surgically postmenopausal women, or
- estrogen only for naturally postmenopausal women who have been hysterectomized, or
- a continuous regimen of estrogen plus progestin for naturally postmenopausal women who have not been hysterectomized
- or not be on any hormone therapy (having stopped hormone therapy at least 12 weeks prior to screening;
Who cannot join
- have any uncontrolled acute diseases or had a major surgical operation requiring hospitalization within 1 month of screening;
- have uncontrolled or chronic diseases, such as hypertension (with diastolic blood pressure > 95 mm Hg on medication), systemic lupus erythematosus, or rheumatoid arthritis;
- have a history of myocardial infarction, bypass surgery, stroke, pulmonary embolism, or deep vein thrombosis;
- have a history of cancer within the last 5 years (except for basal cell carcinoma with a documented 6 month remission), abnormal vaginal bleeding, or tuberculosis;
- have uncontrolled diabetes mellitus with HbA1C > 7.5% (Note: only subjects who have diabetes mellitus or a fasting serum glucose level at the screening visit above the laboratory's upper limit of normal for the reference range will have HbA1C tested prior to randomization.);
- have any abnormal clinical laboratory values at screening assessed as clinically significant by the Investigator;
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- have a serum thyroid stimulating hormone (TSH) value outside the normal laboratory range, confirmed by free T4 levels outside the normal laboratory range;
- have current severe dermatological problems (e.g., severe or cystic acne), including concomitant skin disease or a history of drug-induced contact dermatitis;
- have participated in a cumulative irritation test within the past 12 weeks, or have a known or suspected hypersensitivity or allergy to any transdermal systems including components of the patches used in this study;
- currently use or have a history of any androgen treatment within 6 months prior to screening, or use dehydroepiandrosterone 25 mg per day, or St. John's Wort within 4 weeks prior to baseline. Due to the large number of herbal remedies available, all other herbal supplements will be reviewed by the Sponsor during screening;
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Antonio Pizarro, MD
Fort Myers, Florida, 33901
Maria J Gulierrez, MD
Miramar, Florida, 33025
Robert J Schwab, MD
Omaha, Nebraska, 68154
David R Mathews, MD
Overland Park, Kansas, 66211
About this study
Official title: An Open-label, Multiple-dose, Randomized, Two-period Crossover Study to Assess Bioequivalence of the 300 Mcg/Day Testosterone Reduced-size Patch (14 cm2) Relative to the 300 Mcg/Day Testosterone Reference Patch (28 cm2)
This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy (i.e., estrogen for surgically postmenopausal women or a continuous regimen of estrogen plus progestin for naturally postmenopausal women) restricted to approved oral or transdermal regimens only, or not on concomitant hormone therapy.
- Conditions
- Healthy
- Being tested
- testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosteroneDrug
28 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
testosteroneDrug
14 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 28 cm2 testosterone patch Receives: Drug: testosterone |
| 2 | Experimental | 14 cm2 testosterone patch Receives: Drug: testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence of two testosterone patches based on baseline-corrected (AUCτ) and baseline-corrected maximum serum concentrations of total testosterone and free testosterone at steady-state
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela X Qu, MD, MS, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791856
- Sponsor's protocol ID
- 2007016
- Status last verified
- Apr 2013
- First submitted
- 14 Nov 2008
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose, Randomized, Two-period Crossover Study to Assess Bioequivalence of the 300 Mcg/Day Testosterone Reduced-size Patch (14 cm2) Relative to the 300 Mcg/Day Testosterone Reference Patch (28 cm2)
- ClinicalTrials.gov ID
- NCT00791856
- Acronym / sponsor ID
- 2007016
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Nov 2008 (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 is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy (i.e., estrogen for surgically postmenopausal women or a continuous regimen of estrogen plus progestin for naturally postmenopausal women) restricted to approved oral or transdermal regimens only, or not on concomitant hormone therapy.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: testosterone28 cm2 testosterone patch |
| 2 | Experimental | Drug: testosterone14 cm2 testosterone patch |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- be a surgically postmenopausal female between 20 and 70 years of age who had a hysterectomy and bilateral oophorectomy at least 6 months prior to screening, or be a healthy naturally postmenopausal female between 50 and 70 years of age who had experienced amenorrhea for at least 12 months prior to screening;
- be in good general health based on medical history, physical examination, and laboratory evaluation;
- have had a mammogram, with no clinically significant abnormalities, within the preceding 12 months in subjects > 40 years of age;
- be on a stable dose of approved hormone therapy restricted to oral or transdermal regimens (vaginal products are not acceptable) for a period of at least 12 weeks prior to screening:
- or not be on any hormone therapy (having stopped hormone therapy at least 12 weeks prior to screening;
Key exclusion criteria (10 listed)
- have any uncontrolled acute diseases or had a major surgical operation requiring hospitalization within 1 month of screening;
- have uncontrolled or chronic diseases, such as hypertension (with diastolic blood pressure > 95 mm Hg on medication), systemic lupus erythematosus, or rheumatoid arthritis;
- have a history of myocardial infarction, bypass surgery, stroke, pulmonary embolism, or deep vein thrombosis;
- have a history of cancer within the last 5 years (except for basal cell carcinoma with a documented 6 month remission), abnormal vaginal bleeding, or tuberculosis;
- have uncontrolled diabetes mellitus with HbA1C > 7.5% (Note: only subjects who have diabetes mellitus or a fasting serum glucose level at the screening visit above the laboratory's upper limit of normal for the reference range will have HbA1C tested prior to randomization.);
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 |
|---|---|---|
| testosterone28 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used | Drug | 1 |
| testosterone14 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used | Drug | 2 |
Primary outcome
Bioequivalence of two testosterone patches based on baseline-corrected (AUCτ) and baseline-corrected maximum serum concentrations of total testosterone and free testosterone at steady-state
Time frame: 12 days
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 17 Apr 2013.
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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.
Angela X Qu, MD, MS study director
Procter and Gamble
4 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 testosterone in people with Healthy, run by Warner Chilcott at 4 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 8 inclusion and 10 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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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.
What does the primary outcome measure?
Bioequivalence of two testosterone patches based on baseline-corrected (AUCτ) and baseline-corrected maximum serum concentrations of total testosterone and free testosterone at steady-state (time frame: 12 days). 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 17 Apr 2013.