Phase 2
N=126
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
Atrophy · Vaginal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00630539 ↗Enrolled (actual)
126
Serious AEs
0.8%
Results posted
Jun 2013
Primary outcome: Primary: Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear — -3.0; -2.8; -24.1; -26.8 percentage of parabasal cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Ospemifene 5 mg (Drug); Ospemifene 15 mg (Drug); Ospemifene 30 mg (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Shionogi
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear |
-3.0; -2.8; -24.1; -26.8 | — |
| PRIMARY Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear |
0.2; 0.9; 5.0; 5.6 | — |
| PRIMARY Mean Change From Baseline in Vaginal pH |
-0.12; -0.26; -0.53; -0.78 | — |
| SECONDARY Visual Evaluation of Vagina (by Gynecological Examination) |
14.7; 35.3; 24.2; 36.4; 10.3; 55.2 | — |
| SECONDARY Mean Change From Baseline in Vaginal pH |
-0.12; -0.26; -0.53; -0.78 | — |
| SECONDARY Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index |
0.6; 0.6; 2.5; 5.0 | — |
| SECONDARY Mean Change From Baseline in Estradiol Levels |
-0.004; 0.004; -0.010; -0.003 | — |
| SECONDARY Mean Change From Baseline in Luteinizing Hormone Levels |
-1.36; -2.89; -0.34; -3.78 | — |
| SECONDARY Mean Change From Baseline in Follicle Stimulating Hormone Levels |
-10.36; -7.04; -5.99; -15.32 | — |
| SECONDARY Mean Change From Baseline in Sex Hormone Binding Globulin Levels |
-2.4; 2.9; 6.3; 18.0 | — |
| SECONDARY Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index |
-0.6; -0.6; -19.7; -22.0 | — |
Summary
The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.
Eligibility Criteria
Inclusion Criteria
- Naturally or surgically menopausal
- 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
Data sourced from ClinicalTrials.gov (NCT00630539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.