Phase 3
N=919
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
Atrophy · Vaginal Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00729469 ↗Enrolled (actual)
919
Serious AEs
1.4%
Results posted
Jun 2013
Primary outcome: Primary: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) — -3.7; -31.7 percentage of parabasal cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ospemifene 60 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Shionogi
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) |
-3.7; -31.7 | — |
| PRIMARY Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) |
3.3; 12.4 | — |
| PRIMARY Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) |
-0.24; -0.92 | — |
| PRIMARY Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) |
14; 23; 39; 51; 52; 39 | — |
| PRIMARY Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) |
0.0; -40.2 | — |
| PRIMARY Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) |
1.7; 12.3 | — |
| PRIMARY Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) |
-0.07; -0.94 | — |
| PRIMARY Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) |
47; 67; 70; 93; 76; 82 | — |
| SECONDARY Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) |
-2.8; -31.2 | — |
| SECONDARY Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) |
3.6; 12.7 | — |
| SECONDARY Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) |
-0.21; -0.81 | — |
| SECONDARY Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) |
9; 11; 25; 31; 57; 67 | — |
| SECONDARY Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) |
-0.15; -0.82 | — |
| SECONDARY Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) |
34; 39; 64; 72; 84; 97 | — |
| SECONDARY Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) |
-0.8; -37.8 | — |
| SECONDARY Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) |
1.9; 13.0 | — |
Summary
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
Eligibility Criteria
Inclusion Criteria
- Naturally or surgically menopausal
- Moderate or severe symptoms of vaginal atrophy
- 5% or fewer superficial cells in maturation index of vaginal smear
- Vaginal pH greater than 5.0
- Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization
Exclusion Criteria
- Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
- Current vaginal infection requiring medication
- Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.
uterine or vaginal prolapse of Grade 2 or higher)
- Previous participation in any other ospemifene study
Data sourced from ClinicalTrials.gov (NCT00729469). 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.