Phase 3
Completed N=826
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
Atrophy · Vaginal Diseases
Source: ClinicalTrials.gov NCT00276094 ↗
Enrolled (actual)
826
Serious AEs
1.1%
Results posted
Jun 2013
Primary outcomePrimary: Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness — -1.22; -1.26; -0.84 Units on a scale
Summary
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness |
-1.22; -1.26; -0.84 | — |
| PRIMARY Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity |
-1.02; -1.19; -0.89 | — |
| PRIMARY Mean Change From Baseline in Vaginal pH |
-0.67; -1.01; -0.096 | — |
| PRIMARY Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear |
-21.9; -30.1; 3.98 | — |
| PRIMARY Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear |
7.78; 10.8; 2.18 | — |
| SECONDARY Change From Baseline in Visual Evaluation of the Vagina |
-0.50; -0.60; -0.037; -0.75; -0.93; -0.30 | — |
| SECONDARY Change From Baseline in Severity of VVA Symptoms |
-0.96; -1.17; -0.63; -0.77; -0.87; -0.57 | — |
| SECONDARY Change From Baseline in Estradiol Levels |
-1.44; 1.02; 0.30 | — |
| SECONDARY Change From Baseline in Follicle Stimulating Hormone Levels |
-5.93; -8.71; -1.33 | — |
| SECONDARY Change From Baseline in Luteinizing Hormone Levels |
-2.85; -3.73; 0.41 | — |
| SECONDARY Change From Baseline in Sex Hormone Binding Globulin Levels |
11.1; 22.8; -2.17 | — |
| SECONDARY Change From Baseline in Testosterone (Free) Levels |
0.002; -0.031; -0.008 | — |
| SECONDARY Change From Baseline in Testosterone (Total) Levels |
1.55; 1.92; -0.059 | — |
| SECONDARY Change From Baseline in Urinary Symptoms |
49; 63; 60; 24; 25; 22 | — |
Eligibility Criteria
Inclusion Criteria
- Naturally or surgically postmenopausal
- Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
- Vaginal pH greater than 5.0
- 5% or fewer superficial cells in maturation index of vaginal smear
Exclusion Criteria
- Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
- Abnormal Pap smear
- Uterine bleeding of unknown origin or uterine polyps
- Current vaginal infection requiring medication
Data sourced from ClinicalTrials.gov (NCT00276094). 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. Informational only — not medical advice.