Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01024491
• Date of registration: 30/11/2009
• Prospective Registration: No
• Primary sponsor: MorePharma Corporation
• Public title: Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation
• Scientific title: A Parallel Randomized Double Blind Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation
• Date of first enrolment: August 2008
• Target sample size: 174
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01024491
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Mexico

Contacts

• Name: Eusebio Rubio-Aurioles, M.D, Ph.D.
• Affiliation: Asociacion Mexicana para la Salud Sexual, A.C.

Key inclusion & exclusion criteria

Inclusion Criteria:

- men between 20 and 70 years of age

- with a stable relationship with a female partner

- with the intention to continue with the same partner for the duration of the study

- with diagnosis of premature ejaculation according to the criteria established in the
Diagnostic and Statistical Manual of Mental Disorders IV edition, Revised Text for at
least 6 months before inclusion

- with an Intravaginal Ejaculatory Latency Time (IELT) = 3 minutes in at least 75 % of
a minimum of three sexual encounters, elapsing between them at least 18 hours during
the selection phase of the study

- with agreement to avoid pregnancy or planned surgery during the study,

- female participants should not be pregnant at the inclusion

- both male and female partners had to agree to participate and to sign the informed
consent form

Exclusion Criteria:

- any medical or surgical condition that could be associated with the initiation of
premature ejaculation for secondary PE

- history of myocardial infarction or stroke in the last 6 months

- hemorrhagic disorder, hepatitis B or C, HIV infection, penile implant surgery at any
time

- alcohol or drug abuse in the last 2 years

- any medical or psychiatric condition that could interfere with study procedures and
evaluations

- uncontrolled diabetes

- hypotension (defined as systolic/diastolic blood pressure < 90/50 mm Hg)

- uncontrolled hypertension

- diagnosis of erectile dysfunction or a score = 21 in the erectile function domain of
the International Index of Erectile Function (IIEF) at inclusion

- treatment with any investigational drug in the last month or 5 times the half life of
the drug

- use of medications that could enhance the effect of paroxetine,

- known intolerance to selective serotonin recapture inhibitors

- hypoactive sexual desire not caused by PE

- sexual dysfunction in the female partner that could interfere with participation

- any other significant clinical conditions that could interfere with study procedures

- employees of research sites and relatives of researchers



Age minimum: 20 Years
Age maximum: 70 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Premature Ejaculation

Intervention(s)

Drug: paroxetine

Drug: placebo

Primary Outcome(s)

Intravaginal Ejaculatory Latency Time (IELT) [Time Frame: Visit 2 Baseline, Visit 3 and Visit end of treatment, at 2, 6 and 12 weeks after entry to study respectively]

Secondary Outcome(s)

Score of the control domain of the Index of Premature Ejaculation [Time Frame: Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively]

Sexual desire domain of the International Index of Erectile Function [Time Frame: Visit 1 Screening,Visit 2 Baseline,Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively]

Score of the distress with ejaculation domain of the Index of Premature Ejaculation [Time Frame: Visit 1 Screning, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively]

Score of the sexual satisfaction domain of the Index of Premature Ejaculation [Time Frame: Visit 1 Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively]

Erectile function domain of the International Index of Erectile Function [Time Frame: Visit 1 Screening, Visit 2 Baseline, Visit 3 and Viit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively]

Secondary ID(s)

MPEP-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors