E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036596 |
E.1.2 | Term | Premature ejaculation |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To explore the safety and efficacy profile of a range of doses of BOTOX for the treatment of premature ejaculation in male patients |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |