Clinical trial NCT01230762: An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
Official title: An Open Label Study of the Long-term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ejaculation
Erectile Dysfunction
Sexual Dysfunction
Keywords: Dapoxetine, Orgasmic disorder
Premature ejaculation
Sexual dysfunction
Sexual intercourse
Ejaculation
Erectile Dysfunction
Lead sponsor: Alza Corporation, DE, USA
Sponsor class: INDUSTRY
First posted: 2010-10-29
Enrollment: 1774
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events reported
timeFrame: Up to 9 months
measure: Results from physical examinations
timeFrame: Months 3 and 9 or termination visit
measure: Results from vital signs measurements
timeFrame: Months 1, 2 and 6
measure: Results from clinical laboratory tests
timeFrame: Months 1, 3, and 9 or termination visit
measure: Results from ECGs
timeFrame: At the 3 month visit and the 9 month visit/Termination Visit
Secondary outcomes:
measure: Results from patient reported outcomes (PRO) for perception of sexual functioning
timeFrame: During use of dapoxetine for up to 9 months
Other outcomes:
Locations:
Study officials:
affiliation: ALZA
name: Alza Corporation Clinical Trial
role: STUDY_DIRECTOR
References: