Efficacy of two dose Tramadol HCI ODT for premature ejaculation.

  • Research type

    Research Study

  • Full title

    A Randomized, Double-blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects with Premature Ejaculation

  • IRAS ID

    26434

  • Contact name

    Wallace Dinsmore

  • Eudract number

    2009-011410-18

  • Research summary

    This is a phase III, randomised, double-blind, placebo-controlled, multi-center study to evaluate the efficacy of 62 mg and 89 mg of Tramadol HCl ODT on IELT (Intravaginal Ejaculation Latency Time) in male subjects with premature ejaculation. There is a 3 week run-in-period to determine baseline IELT. A 3 week placebo lead-in period, to identify high placebo responders, who will be eligible subjects as long as they meet the inclusion & exclusion criteria. All eligible subjects will be then randomised to receive 62mg or 89mg or matching placebo for 12 weeks. All subjects who complete the double blind treatment period, will be entered into an open-label extension period and will receive 89mg of Tramadol for 12 weeks. This dose may be reduced to 62mg of Tramadol if adverse events interfere with treatment. The objective of this study is to evaluate the efficacy of two different does of Tramadol HCI ODT in delaying the IELT and improve PEP (Premature Ejaculation Profile). The secondary objective is to evaluate the safety of the same two doses of Tramadol when given to delay ejaculation. It is expected that at least 825 subjects will complete the study. Subjects will be evaluated for efficacy and safety at designated intervals during the treatment period. Efficacy measures will consist of the IELT, PEP, the Sexual Quality of Life Questionnaire for men and the Global Satisfaction Questionnaire. Candidates will be male subjects aged between 18 - 65 years, with lifelong premature ejaculation. Subjects must be in stable, monogamous, heterosexual relationship (for 6 months or longer). They must be willing to take study medication as directed at least 2 hours prior to sexual intercourse. They and their partners must be willing to complete the therapeutic trial, all sexual behaviour logs, IELT assessments, questionnaires and interviews.

  • REC name

    HSC REC B

  • REC reference

    09/NIR03/59

  • Date of REC Opinion

    22 Mar 2010

  • REC opinion

    Further Information Favourable Opinion