Premature Ejaculation MedDRA version: 14.1 Level: PT Classification code 10036596 Term: Premature ejaculation System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
Allergan Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: · written informed consent has been obtained from both the patient and his female partner · male aged 18 to 50 years · in a stable monogamous sexual relationship with a female partner for at least 6 months (with the intention to continue with the same partner for the duration of the study) · diagnosed with lifelong PE (defined as symptoms starting at the time the patient became sexually active) · meets PE criteria (based on the 2008 International Society of Sexual Medicine [ISSM] definition) · previously tried at least one form of therapy for PE (eg, behavioral therapy, topical therapy, or oral therapy) but patient remains dissatisfied · mean screening intravaginal ejaculatory latency time (IELT) of = 1 minute (calculated from the 4 most recent evaluable events recorded on the screening sexual event log [SEL]) -None of the 4 most recent evaluable events can have an IELT measurement > 2 minutes. -It must not have taken longer than 28 days to obtain 4 evaluable events. -Evaluable event is defined as an ejaculation which was recorded in the SEL to have occurred prior to intended vaginal penetration or during vaginal penetration (see Section 6.3.4.1 for further details). · patient and partner are willing and able to engage in vaginal intercourse at least 4 times per month for the duration of the study · patient and partner agree not to change their usual sexual practices during the study (eg, amount of foreplay, use of lubrication, use of behavioral techniques, and/or type of contraception) · patient and partner agree not to use condoms for the duration of the study (screening and posttreatment) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · any medical or surgical condition that could be associated with secondary (acquired) PE or patient has PE which is situational or attributable to relationship issues · a score of < 25 on the International Index of Erectile Function - Erectile Dysfunction (IIEF-ED) questionnaire at screening · patient is unable or unwilling to discontinue (ie, washout) prohibited medications from at least 28 days prior to efficacy measurements, and throughout the duration of the study. Prohibited medications include: 1) dapoxetine (Priligy™, Kutub™) or any other medications with selective serotonin reuptake inhibitor (SSRI) activity 2) tramadol or any other medications with serotonin norepinephrine reuptake inhibitor (SNRI) activity or with opiate activity 3) antidepressant, antipsychotic, antiepileptic, neuroleptic medications, or medications with psychoactive properties 4) topical penile treatments (eg, anesthetics, herbal treatments) for PE or any other indication 5) penile injections (eg, intracavernosal injections) for PE or any other indication 6) phosphodiesterase type 5 (PDE-5) inhibitors, alprostadil, or any other treatments for erectile dysfunction (ED) or any other type of sexual dysfunction 7) See Section 4.5.2 for a full list of prohibited medications requiring washout. · patient has had prior genital, prostatic or lower urinary tract surgery (other than vasectomy or circumcision) · clinically significant sexual dysfunction in the female partner that could interfere with study participation or impact the sexual relationship (eg, decreased libido, painful intercourse) · the partner is known to be pregnant or there is an intention for the partner to become pregnant during the course of the study · any uncontrolled systemic disease · history of any neurologic condition that may affect sexual function or findings at study entry which may be consistent with a neurological condition that may affect sexual function · medication in the last 6 months for depression, psychiatric disorders (including post traumatic stress syndrome), mood disorders, schizophrenia, alcohol abuse, substance abuse, or anxiety disorders · patient has excessive alcohol usage in the opinion of the investigator · botulinum toxin therapy of any serotype for any non-urological condition or usage (eg, cosmetic, chronic migraine) during the 12 weeks prior to screening, or planned usage during the course of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the safety and efficacy profile of a range of doses of BOTOX for the treatment of premature ejaculation in male patients;Secondary Objective: Not Applicable;Primary end point(s): Intravaginal ejaculatory latency time (IELT) as measured by stopwatch and captured on the sexual intercourse diary (SID) and provides an objective assessment of the pharmacologic effects of study treatment on PE. ;Timepoint(s) of evaluation of this end point: IELT change, across all the evaluable ejaculatory attempts recorded in the SID, from baseline to the end of the 12 weeks follow up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United Kingdom, United States
Contacts
Public ContactAllergan Ltd. EU Regulatory Affairs
Allergan Limited
Outcome results
None listed