A Phase 2 multi-center, open label, long-term extension trial to assess the safety and sustained efficacy of oral UK-390,957 administered as required in adult men with premature ejaculation. - N/A
- Conditions
- Premature EjaculationMedDRA version: 7.0Level: LLTClassification code 10036596
- Registration Number
- EUCTR2004-003737-13-AT
- Lead Sponsor
- Pfizer Corporation Austria Ges.m.b.H., Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1058
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into thetrial:
1. Subject is a male =18 years of age.
2. Subject has provided written informed consent.
3. Subject continues to have a monogamous, stable heterosexual relationship.
4. Subject and his partner are willing to use a timer for attempts at sexual intercourse for 14 days prior to visits at 12, 24 and 52 weeks.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects presenting with any of the following will not be included in the trial:
1. Subject develops other forms of sexual dysfunction (erectile, retrograde, anejaculation, painful ejaculation, hypoactive sexual desire disorder, inhibited or absent orgasms).
2. Subject who requires any form of treatment for depression including counseling or psychotherapy or with a past medical history of mania, hypomania or bipolar disorder.
3. Since completing the previous trial the subject has begun taking SSRIs or tricyclic antidepressants or drugs with significant interactions with SSRIs such as: anticoagulants, anti-migraine agents, theophylline, tryptophan, St. John’s Wort, lithium, dextromethorphan, reversible or irreversible Monoamine Oxidase inhibitors (RIMAs or MAOIs).
4. Subject has developed a condition for which SSRIs are contraindicated, such as:a. History of narrow angle glaucomab. History of seizuresc. History of bleeding disordersd. At risk for volume depletione. Clinically significant (severe) hepatic or renal impairment.
5. Subject has developed severe allergies or hypersensitivity or multiple adverse drug reactionsto the class of SSRIs.
6. Subject intends to donate blood or blood products during the period of the trial or within 1 month of the trial’s completion.
7. Subject has developed any medical or psychological condition or social circumstances that would impair his ability to participate reliably in the trial or who may increase risk to himself or others by participating.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and toleration of UK-390,957 administered as required by men withPremature ejaculation who successfully complete 1 of the following Pfizer sponsored trials:A3871022, A3871027 or A3871029. Sustained efficacy will be evaluated after 12, 24 and52 weeks of open-label therapy.;Secondary Objective: ;Primary end point(s): Safety<br>1. Will be determined by laboratory testing (only clinically significant laboratory abnormalities will be summarized).<br>2. Adverse events will be monitored. Serious adverse events, discontinuations due to adverse events during the study and following withdrawal will be summarized.<br>3. Adverse events will be considered with respect to frequency of drug use.
- Secondary Outcome Measures
Name Time Method