EjaculationPhase 3NCT01230762
An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
A Phase 3 study testing dapoxetine in people with Ejaculation and Erectile Dysfunction, run by Alza Corporation, DE, USA.
Trial summary
The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid ejaculation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Ejaculation, Erectile Dysfunction, Sexual Dysfunction
- What is being tested?
- dapoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,774 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Apr 2005
- Phase
- Phase 3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment within 30 days of completion of 1 of the 2 Phase 3 controlled studies (ALZA Study C-2002-012 or Study C-2002-013)
- In the opinion of the Investigator, the patient could safely continue the use of dapoxetine treatment
- Had a systolic blood pressure of <=180 mm Hg and a diastolic blood pressure <=100 mm Hg
- Agreement by patient's sexual partner (if of childbearing potential) to ensure use of a medically acceptable method of contraception for the duration of the study Exclusion Criteria:
- Currently taking any any protocol-defined prohibited medications
- Reported a diagnosis of any sexually transmitted disease, Had a new allergy or hypersensitivity to dapoxetine or other selective serotonin reuptake inhibitors
- In the opinion of the Investigator is incapable of following the study schedule for any reason
Who cannot join
None listed.
About this study
Official title: An Open Label Study of the Long-term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
The purpose of this study is to evaluate the long-term safety of dapoxetine in men with rapid ejaculation.
Read the detailed description
This is a multicenter, open-label (patients and Investigators will know the name of the drug that they are receiving) study to evaluate the long-term safety and efficacy of dapoxetine therapy in adult men with premature (rapid) ejaculation (PE) who participated in 1 of 2 previous studies of dapoxetine ( ALZA Protocol C-2002-012 or C-2002-013). The length of the study will be up to 9 months. During the study, patients will be monitored for safety by review of adverse events and findings from routine laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations. Oral tablets of dapoxetine (30 mg or 60 mg) will be self-administered by patients once daily, as needed, for up to 9 months. No more than 1 dose within a 24-hour period should be taken. If the 60 mg dose of dapoxetine is not well tolerated, the dose may be decreased to 30 mg dapoxetine for the remainder of the study. Patients who do not tolerate the 30 mg dose of dapoxetine should be discontinued from the study.
- Conditions
- Ejaculation, Erectile Dysfunction, Sexual Dysfunction
- Being tested
- dapoxetine
- Keywords
- Dapoxetine, Orgasmic disorder, Premature ejaculation, Sexual dysfunction, Sexual intercourse, Ejaculation, Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Premature Ejaculation, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapoxetineDrug
60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | dapoxetine 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months Receives: Drug: dapoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events reported
Measured: Up to 9 months
Results from physical examinations
Measured: Months 3 and 9 or termination visit
Results from vital signs measurements
Measured: Months 1, 2 and 6
Results from clinical laboratory tests
Measured: Months 1, 3, and 9 or termination visit
Results from ECGs
Measured: At the 3 month visit and the 9 month visit/Termination Visit
Secondary outcomes (1)
Results from patient reported outcomes (PRO) for perception of sexual functioning
Measured: During use of dapoxetine for up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EjaculationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alza Corporation Clinical Trial, Study director, ALZA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230762
- Sponsor's protocol ID
- CR005041
- Other IDs
- C-2002-014
- Status last verified
- Jan 2011
- First submitted
- 28 Oct 2010
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of the Long-term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
- ClinicalTrials.gov ID
- NCT01230762
- Acronym / sponsor ID
- CR005041
- Conditions
- Ejaculation, Erectile Dysfunction, Sexual Dysfunction
- Keywords
- Dapoxetine, Orgasmic disorder, Premature ejaculation, Sexual dysfunction, Sexual intercourse, Ejaculation, Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,774 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study completion
- Apr 2005 (actual)
- First posted
- 29 Oct 2010 (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 evaluate the long-term safety of dapoxetine in men with rapid ejaculation.
Detailed description
This is a multicenter, open-label (patients and Investigators will know the name of the drug that they are receiving) study to evaluate the long-term safety and efficacy of dapoxetine therapy in adult men with premature (rapid) ejaculation (PE) who participated in 1 of 2 previous studies of dapoxetine ( ALZA Protocol C-2002-012 or C-2002-013). The length of the study will be up to 9 months. During the study, patients will be monitored for safety by review of adverse events and findings from routine laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations. Oral tablets of dapoxetine (30 mg or 60 mg) will be self-administered by patients once daily, as needed, for up to 9 months. No more than 1 dose within a 24-hour period should be taken. If the 60 mg dose of dapoxetine is not well tolerated, the dose may be decreased to 30 mg dapoxetine for the remainder of the study. Patients who do not tolerate the 30 mg dose of dapoxetine should be discontinued from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: dapoxetinedapoxetine 60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrollment within 30 days of completion of 1 of the 2 Phase 3 controlled studies (ALZA Study C-2002-012 or Study C-2002-013)
- In the opinion of the Investigator, the patient could safely continue the use of dapoxetine treatment
- Had a systolic blood pressure of <=180 mm Hg and a diastolic blood pressure <=100 mm Hg
- Agreement by patient's sexual partner (if of childbearing potential) to ensure use of a medically acceptable method of contraception for the duration of the study Exclusion Criteria:
- Currently taking any any protocol-defined prohibited medications
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| dapoxetine60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months | Drug | 001 |
Primary outcome
Adverse events reported
Time frame: Up to 9 months
Results from physical examinations
Time frame: Months 3 and 9 or termination visit
Results from vital signs measurements
Time frame: Months 1, 2 and 6
Results from clinical laboratory tests
Time frame: Months 1, 3, and 9 or termination visit
Results from ECGs
Time frame: At the 3 month visit and the 9 month visit/Termination Visit
1 secondary outcome
Results from patient reported outcomes (PRO) for perception of sexual functioning
Time frame: During use of dapoxetine for up to 9 months
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 19 May 2011.
- An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation.Link provided by the sponsor.
Related trials for Ejaculation
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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.
Alza Corporation Clinical Trial study director
ALZA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dapoxetine in people with Ejaculation and Erectile Dysfunction, run by Alza Corporation, DE, USA.
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 7 inclusion and 0 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Adverse events reported (time frame: Up to 9 months). The study lists 5 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 19 May 2011.