Erectile DysfunctionPhase 2NCT01810575
Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction
A Phase 2 study of Erectile Dysfunction, run by Warner Chilcott at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety \& efficacy of a single dose of alprostadil cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile dysfunction. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Apr 2013
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subject aged 40 or older of any race
- History of ED (erectile dysfunction) of at least 3 months duration defined as inability to attain \& maintain an erection of the penis sufficient to permit satisfactory sexual intercourse
- Completed and signed informed consent prior to any study related procedures
Who cannot join
- History/presence any significant disease that Investigator feels will interfere with course of the study
- Anatomic deformity of penis
- History/presence alcoholism or drug abuse/dependence within past 2 years (discretion of Investigator)
- Participation in investigational study drug trial within 30 days prior to randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
Warner Chilcott Investigational Study Site
Purchase, New York, 10755
About this study
Official title: A Study to Assess the Relative Efficacy and Safety of a Single Dose of Alprostadil Cream Combined With 2 Concentrations of WC3036 Compared to Vehicle in Subjects With Erectile Dysfunction
The purpose of this study is to assess the safety \& efficacy of a single dose of alprostadil cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- WC3036-11F/Alprostadil in Vehicle 2.5%, WC3036-12F/Alprostadil in Vehicle 0.5%, WC3036-13P/Vehicle Only 0.5%
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WC3036-11F/Alprostadil in Vehicle 2.5%Drug
Also called 11F
330 mcg alprostadil in 2.5% vehicle
WC3036-12F/Alprostadil in Vehicle 0.5%Drug
Also called 12F
330 mcg alprostadil in 0.5% vehicle
WC3036-13P/Vehicle Only 0.5%Drug
Also called Vehicle
100 mg cream vehicle 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| WC3036-11F/Alprostadil in Vehicle 2.5% | Active comparator | Treatment A Receives: Drug: WC3036-11F/Alprostadil in Vehicle 2.5% |
| WC3036-12F/Alprostadil in Vehicle 0.5% | Experimental | Treatment B Receives: Drug: WC3036-12F/Alprostadil in Vehicle 0.5% |
| WC3036-13P/Vehicle Only 0.5% | Placebo comparator | Treatment C Receives: Drug: WC3036-13P/Vehicle Only 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile rigidity
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Measured: Visit 1 / Up to 5 days ± 3 days
Penile rigidity
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Measured: Visit 2 / Up to 9 days ± 3 days
Penile rigidity
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Measured: Visit 3 / Up to 14 Days
Secondary outcomes (3)
Quality of erection
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Measured: Visit 1 / Up to 5 days ± 3 days
Quality of erection
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Measured: Visit 2 / Up to 9 days ± 3 days
Quality of erection
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Measured: Visit 3 / Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Re-assessment of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vilma Sniukiene, MD, Study director, Warner Chilcott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810575
- Sponsor's protocol ID
- PR-13311
- Status last verified
- Aug 2014
- First submitted
- 27 Feb 2013
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Relative Efficacy and Safety of a Single Dose of Alprostadil Cream Combined With 2 Concentrations of WC3036 Compared to Vehicle in Subjects With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT01810575
- Acronym / sponsor ID
- PR-13311
- Conditions
- Erectile Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Re-assessment of study
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Mar 2013 (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.
The purpose of this study is to assess the safety \& efficacy of a single dose of alprostadil cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WC3036-11F/Alprostadil in Vehicle 2.5% | Active comparator | Drug: WC3036-11F/Alprostadil in Vehicle 2.5%Treatment A |
| WC3036-12F/Alprostadil in Vehicle 0.5% | Experimental | Drug: WC3036-12F/Alprostadil in Vehicle 0.5%Treatment B |
| WC3036-13P/Vehicle Only 0.5% | Placebo comparator | Drug: WC3036-13P/Vehicle Only 0.5%Treatment C |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male subject aged 40 or older of any race
- History of ED (erectile dysfunction) of at least 3 months duration defined as inability to attain \& maintain an erection of the penis sufficient to permit satisfactory sexual intercourse
- Completed and signed informed consent prior to any study related procedures
Key exclusion criteria (4 listed)
- History/presence any significant disease that Investigator feels will interfere with course of the study
- Anatomic deformity of penis
- History/presence alcoholism or drug abuse/dependence within past 2 years (discretion of Investigator)
- Participation in investigational study drug trial within 30 days 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 |
|---|---|---|
| WC3036-11F/Alprostadil in Vehicle 2.5%Also: 11F330 mcg alprostadil in 2.5% vehicle | Drug | WC3036-11F/Alprostadil in Vehicle 2.5% |
| WC3036-12F/Alprostadil in Vehicle 0.5%Also: 12F330 mcg alprostadil in 0.5% vehicle | Drug | WC3036-12F/Alprostadil in Vehicle 0.5% |
| WC3036-13P/Vehicle Only 0.5%Also: Vehicle100 mg cream vehicle 0.5%. | Drug | WC3036-13P/Vehicle Only 0.5% |
Primary outcome
Penile rigidity
Time frame: Visit 1 / Up to 5 days ± 3 days
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Penile rigidity
Time frame: Visit 2 / Up to 9 days ± 3 days
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Penile rigidity
Time frame: Visit 3 / Up to 14 Days
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
3 secondary outcomes
Quality of erection
Time frame: Visit 1 / Up to 5 days ± 3 days
Quality of erection
Time frame: Visit 2 / Up to 9 days ± 3 days
Quality of erection
Time frame: Visit 3 / Up to 14 days
Results and safety
The study was stopped early (reason given: Re-assessment of study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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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.
Vilma Sniukiene, MD study director
Warner Chilcott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Erectile Dysfunction, run by Warner Chilcott 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 4 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: stopped early, as of the sponsor's last update on 12 Aug 2014. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Re-assessment of study). Results are not available in the source record.
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?
Penile rigidity (time frame: Visit 1 / Up to 5 days ± 3 days). The study lists 3 primary outcomes in all. 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 12 Aug 2014.