Ejaculation, Erectile Dysfunction, Sexual Dysfunction
Conditions
Keywords
Dapoxetine, Orgasmic disorder, Premature ejaculation, Sexual dysfunction, Sexual intercourse, Ejaculation, Erectile Dysfunction
Brief summary
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.
Interventions
DRUGdapoxetine
60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months
Sponsors
Alza Corporation, DE, USA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events reported | Up to 9 months |
| Results from physical examinations | Months 3 and 9 or termination visit |
| Results from vital signs measurements | Months 1, 2 and 6 |
| Results from clinical laboratory tests | Months 1, 3, and 9 or termination visit |
| Results from ECGs | At the 3 month visit and the 9 month visit/Termination Visit |
Secondary
| Measure | Time frame |
|---|---|
| Results from patient reported outcomes (PRO) for perception of sexual functioning | During use of dapoxetine for up to 9 months |
Outcome results
None listed