Summary:
The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness.
Qualified Participants Must:
• Have moderate to severe vaginal dryness
•
Be a postmenopausal female matching one of the following criteria:
- A) Be 45 years of age or older. Her last spontaneous menstrual bleeding must have been 12 months or more prior to screening
- B) Be 45 years of age or older and does not remember the date of her last spontaneous menstrual bleeding and has follicle-stimulating hormone (FSH) levels greater than 40 IU/L
- C) Have had a hysterectomy WITHOUT oophorectomy and serum FSH levels over 40 IU/L
- D) Have had a bilateral oophorectomy at least 6 weeks prior to screening
•
Not have a body mass index (BMI) 37 or greater
•
Not have uncontrolled hypertension
•
Not have taken a SERM (raloxifene, tamoxifen, toremifene, or clomiphene), tibolone, or any other medication that is expected to have clinically-significant estrogenic and/or antiestrogenic effects within 60 days prior to screening
•
Not have previously taken ospemifene
Qualified Participants May Receive:
Compensation for time and travel.
Free study medications.
Free laboratory assessments.
Free medical imaging required for the study.
Free medical evaluation by board certified, university trained, physicians.