Zestra in Women With Mixed Sexual Dysfunction
Condition: Sexual Dysfunction, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the clinical efficacy and safety of Zestra(TM) in
      women with acquired mixed desire/interest/arousal/orgasm disorders under conditions of home
      usage. The primary efficacy hypothesis will compare the effect of Zestra versus placebo on
      the incidence of "successful and satisfactory" sexual encounters.
    

Detailed description: 
      This Phase 3 study is being conducted to evaluate the efficacy and safety of Zestra(TM)
      compared to a placebo oil in women diagnosed as having acquired mixed
      interest/desire/arousal/orgasm disorders with varying presentations of each component in
      conditions of home use in conjunction with sexual activities. The study is a randomized,
      placebo-controlled, double-blind, parallel design trial. After subject screening, there is an
      open-label, placebo run-in period of four weeks, followed by a double-blinded 12 week
      treatment period. This design is consistent with the Paris 2003 recommendations for female
      sexual dysfunction (FSD) clinical trials and the Food and Drug Administration (FDA) Guidance
      on Clinical Development of Products for the Treatment of Female Sexual Dysfunction although
      the duration of active treatment in this study is 12 weeks rather than the 6 months suggested
      by the FDA for Phase 3 studies.

      Primary efficacy assessment will be the subjects' assessments of "successful and
      satisfactory" sexual encounters as recorded in a diary (question 10 in the Female Sexual
      Encounter Profile [FSEP©]). Secondary evaluations of efficacy will include the other FSEP
      questions, a subject self-assessment questionnaire (Female Sexual Function Index [FSFI©]),
      two global assessment questions, a treatment satisfaction questionnaire (WITS©), the Beck
      Depression Inventory, the Dyadic Adjustment Scale (DAS), a consumer testing survey (QualiLife
      Consumer Testing Survey [QCTS©]), and a distress scale (Female Sexual Distress Scale
      [FSDS©]), sexual encounter frequency, and drop-out rates.

      The selection of outcome measures in this study is based on the most current information
      available. The FSEP© has been used in many FSD studies and specifically meets the FDA
      recommendations for a primary outcome measure. The initial validation study of the FSEP© was
      presented at the 11th World Congress of the International Society for Sexual and Impotence
      Research in Buenos Aires in 2004. The FSFI©, the FSDS©, and global assessment questions are
      routinely used in FSD trials, and the first two have been subjects of ongoing validation for
      a number of years. Global assessment questions have historically been used to calculate
      response rates. The QCTS© is a consumer testing survey which addresses issues ultimately
      impinging on product marketability. WITS© is a female oriented treatment satisfaction
      instrument newly developed by Stanley E. Althof, Ph.D., Eric W. Corty, Ph.D., and Miki
      Wieder, M.A., 2004; the authors' authorized use of this instrument in this study is part of
      the ongoing validation for this questionnaire. Since depression can contribute to FSD and FSD
      can contribute to depression, seriously confounding diagnostic and treatment schema, the
      commonly used Beck Depression Inventory will be administered at the end of the baseline
      run-in period and then at the end of the double-blinded treatment period. Relational factors
      have the same confounding issues as depression; thus, the participants' attitudes about their
      relationships with their partners will be assessed at baseline and end of treatment using the
      Dyadic Adjustment Scale. Sexual encounter frequency may prove a useful outcome measure since
      a beneficial effect of treatment may be reinforcing, while lack of efficacy by the placebo
      may be discouraging. A similar hypothesis is the basis of drop-out analysis.
    

Intervention name(s): Non-prescription Zestra(TM): patented formulation
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: female sexual dysfunction; FSD; arousal; orgasm; desire; Zestra; Mixed FSD; Hypoactive sexual desire disorder; Sexual arousal disorder; Orgasmic disorder