Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Warner Chilcott
Age
35–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
