Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
Condition: Vulvovaginal Atrophy
MeSH terms: Dyspareunia; Atrophy
Intervention: WC3011 Estradiol Vaginal Cream; Vehicle
Intervention description: Daily for 14 days followed by 3 times per week for 10 weeks; Daily for 14 days followed by 3 times per week for 10 weeks
Intervention MeSH terms: Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 550.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Vulvovaginal Atrophy; Dyspareunia; Postmenopausal

Summary:

      The purpose of the study is to determine if WC3011 is safe and effective in treating the
      symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant
      self-assessment when compared to vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sexually active with self-identified dyspareunia (pain with sexual activity), at least
             moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)

          -  Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6
             months spontaneous amenorrhea with FSH (follicle stimulating hormone) >40 mIU/mL,6
             weeks postsurgical bilateral oophorectomy with confirmation by FSH >40 mIU/mL,
             surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure
             confirmed by FSH >40 mIU/mL

          -  Age ≥40 years; ≥35 with bilateral oophorectomy

          -  Vaginal pH >5.0

          -  Less than or equal to 5% superficial cells on vaginal wall cytologic smear

          -  Normal clinical breast exam or negative mammogram if ≥ 40 years of age

          -  Negative urine pregnancy test (non-hysterectomized and <12 months amenorrhea)

        Exclusion Criteria:

          -  Enrollment in Sponsor's Study PR-04409 or PR-05812

          -  Participation in clinical trial or use of investigational drug within 30 days prior to
             screening

          -  Known hypersensitivity to estrogen and/or progestin therapy

          -  Known or suspected premalignant or malignant disease or history steroid-dependent
             malignancy

          -  Manifestation or treatment for significant cardiovascular disease (congestive heart
             failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass,
             percutaneous angioplasty or >50% angiographic narrowing of coronary artery

          -  Thrombophlebitis or thromboembolic disorder or history of

          -  Insulin-dependent diabetes mellitus

          -  Increased frequency or severity of headaches while on hormone or estrogen therapy

          -  Currently taking St. John's Wort

          -  Drug/alcohol addiction within past 2 years

          -  Treatment with anticoagulants (heparin or warfarin)

          -  Smoking ≥15 cigarettes/day