Phase 3
Completed N=426
A Clinical Study to Evaluate the Safety of Ospemifene
Atrophy · Vaginal Diseases
Source: ClinicalTrials.gov NCT00566982 ↗
Enrolled (actual)
426
Serious AEs
5.2%
Results posted
Jun 2013
Primary outcomePrimary: Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear — 5.0; -46.0 percentage of parabasal cells
Summary
The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear |
5.0; -46.0 | — |
| PRIMARY Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear |
1.0; 10.3 | — |
| PRIMARY Mean Change From Baseline in Vaginal pH |
-0.16; -1.21 | — |
| SECONDARY Change From Baseline in Estradiol Levels |
0.004; 0.004 | — |
| SECONDARY Change From Baseline in Luteinizing Hormone Levels |
-0.88; -3.16 | — |
| SECONDARY Change From Baseline in Follicle Stimulating Hormone Levels |
-7.63; -19.69 | — |
| SECONDARY Change From Baseline in Sex Hormone Binding Globulin Levels |
-0.8; 31.0 | — |
| SECONDARY Visual Evaluation of the Vagina (Baseline & Week 52) |
10; 20; 74; 241; 28; 12 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00566982). 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.