Charleston, S.C., July 20, 2005 -- QualiLife Pharmaceuticals, Inc. announces the acceptance of its expanded 2005 clinical trial of Zestra TM
by the National Institutes of Health (NIH). This Phase 3 type study will evaluate the efficacy and safety of ZestraTM
compared to placebo oil in 200 women diagnosed with acquired mixed interest/desire/arousal/orgasm disorders in conditions of home use in conjunction with sexual activities. The ZestraTM
study is the only registered study to directly address women's sexual problems.
The study is a randomized, placebo-controlled, double-blind, parallel design trial. Primary efficacy assessment will be the subjects' assessments of "successful and satisfactory" sexual encounters as recorded in a diary (FSEP©). Secondary evaluations of efficacy will include the other diary questions, a subject self assessment questionnaire (Female Sexual Function Index (FSFI)®), two global assessment questions (GAQ), a treatment satisfaction questionnaire (WITS©), the Beck Depression Inventory, the Dyadic Adjustment Scale (DAS), a consumer testing survey (QualiLife Consumer Testing Survey (QCTS©), a distress scale (Female Sexual Distress Scale (FSDS)©), sexual encounter frequency and drop-out rates.
The ZestraTM study description can be viewed at www.ClinicalTrials.gov by entering any of the following search terms: female sexual dysfunction, hypoactive sexual desire disorder, sexual arousal disorder, orgasmic disorder or Zestra. The International Committee of Medical Journal Editors (ICJME) has established a requirement that all clinical trials be entered in a public registry before the onset of patient enrollment, as a condition of consideration for publication. QualiLife intends to update the trial data as the study progresses and to publish the results in a prominent peer-reviewed journal.
ZestraTM femiPage: 1 2 3 4 Related medicine news :1
Contact: Emily Ross
Kupper Parker Communications
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