A Clinical Study to Evaluate the Safety of Ospemifene

• Ospemifene 60 mg (Drug), also known as Osphena®: 60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.
• Placebo (Drug): Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)

Primary outcomes

• Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear [12 weeks]
• Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear [12 weeks]
• Mean Change From Baseline in Vaginal pH [12 weeks]

Secondary outcomes

• Change From Baseline in Estradiol Levels [52 weeks]
• Change From Baseline in Luteinizing Hormone Levels [52 weeks]
• Change From Baseline in Follicle Stimulating Hormone Levels [52 weeks]
• Change From Baseline in Sex Hormone Binding Globulin Levels [52 weeks]
• Visual Evaluation of the Vagina (Baseline & Week 52) [52 weeks]

Sex: Female, ages: 40 Years to 80 Years

Inclusion Criteria:

* Naturally or surgically menopausal
* Intact uterus
* Vaginal pH greater than 5.0
* 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

* Evidence of endometrial hyperplasia, cancer or other pathology
* Abnormal Pap smear
* Uterine bleeding of unknown origin or uterine polyps
* Current vaginal infection requiring medication
* Use of hormonal medications
* Clinically significant abnormal gynecological findings other than signs of vaginal atrophy

Participant flow

Outcome results

• Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear (Primary), Mean, percentage of parabasal cells: Subjects on Placebo (Baseline) 5.0 (-90 to 98); Subjects on Ospemifene 60 mg/Day (Baseline) -46.0 (-100 to 75)
• Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear (Primary), Mean, percentage of superficial cells: Subjects on Placebo (Baseline) 1.0 (-5 to 28); Subjects on Ospemifene 60 mg/Day (Baseline) 10.3 (-5 to 60)
• Mean Change From Baseline in Vaginal pH (Primary), Mean, pH: Subjects on Placebo (Baseline) -0.16 +/- 0.945; Subjects on Ospemifene 60 mg/Day (Baseline) -1.21 +/- 0.912
• Change From Baseline in Estradiol Levels (Secondary), Mean, nmol/L: Subjects on Placebo (Baseline) 0.004 +/- 0.0120; Subjects on Ospemifene 60 mg/Day (Baseline) 0.004 +/- 0.0145
• Change From Baseline in Luteinizing Hormone Levels (Secondary), Mean, U/L: Subjects on Placebo (Baseline) -0.88 +/- 7.738; Subjects on Ospemifene 60 mg/Day (Baseline) -3.16 +/- 8.127
• Change From Baseline in Follicle Stimulating Hormone Levels (Secondary), Mean, U/L: Subjects on Placebo (Baseline) -7.63 +/- 17.083; Subjects on Ospemifene 60 mg/Day (Baseline) -19.69 +/- 18.977
• Change From Baseline in Sex Hormone Binding Globulin Levels (Secondary), Mean, nmol/L: Subjects on Placebo (Baseline) -0.8 +/- 15.41; Subjects on Ospemifene 60 mg/Day (Baseline) 31.0 +/- 27.16
• Visual Evaluation of the Vagina (Baseline & Week 52) (Secondary), Number, participants: Subjects on Placebo (Baseline) 10; Subjects on Placebo (Week 52) 20; Subjects on Ospemifene 60 mg/Day (Baseline) 74; Subjects on Ospemifene 60 mg/Day (Week 52) 241

Adverse events

Time frame: 16 Weeks; From the signing of the informed consent form to the last safety evaluation (Week 12)

Serious adverse events by term

Other adverse events by term