Phase 3
N=631
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
Vaginal Dryness
Bottom Line
View on ClinicalTrials.gov: NCT02638337 ↗Enrolled (actual)
631
Serious AEs
1.3%
Results posted
Apr 2019
Primary outcome: Primary: Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12 — -23.7; -1.9 percentage of cells — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ospemifene (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Shionogi
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12 |
-23.7; -1.9 | <0.0001 sig |
| PRIMARY Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12 |
7.8; 0.6 | <0.0001 sig |
| PRIMARY Change From Baseline in the Vaginal pH at Week 12 |
-1.01; -0.29 | <0.0001 sig |
| PRIMARY Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12 |
-1.29; -0.91 | <0.0001 sig |
| PRIMARY Number of Participants With Adverse Events |
112; 103; 28; 20; 6; 10 | — |
| SECONDARY Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Weeks 4 and 8 |
-21.6; 0.0; -23.7; -1.9 | <0.0001 sig |
| SECONDARY Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Weeks 4 and 8 |
5.6; -0.2; 7.1; -0.2 | <0.0001 sig |
| SECONDARY Change From Baseline in the Vaginal pH |
-0.81; -0.24; -0.95; -0.32 | <0.0001 sig |
| SECONDARY Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Weeks 4 and 8 |
-0.83; -0.62; -1.14; -0.84 | 0.0005 sig |
| SECONDARY Change From Baseline in Vaginal and/or Vulvar Irritation or Itching |
-0.93; -0.99; -1.17; -1.16; -1.38; -1.40 | 0.6263 |
| SECONDARY Change From Baseline in Difficult or Painful Urination |
-1.23; -1.21; -1.42; -1.15; -1.56; -1.38 | 0.8369 |
| SECONDARY Change From Baseline in Vaginal Pain Associated With Sexual Activity |
-1.24; -0.99; -1.41; -1.26; -1.55; -1.21 | 0.0095 sig |
| SECONDARY Change From Baseline in Vaginal Bleeding Associated With Sexual Activity |
-1.17; -1.33; -1.47; -1.58; -1.55; -1.61 | 0.4336 |
| SECONDARY Change From Baseline in Maturation Value |
13.33; -0.65; 15.34; 0.61; 16.19; 1.28 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Were Responders at Week 4, Week 8, and Week 12 |
19.2; 2.6; 27.9; 4.4; 31.5; 6.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Vaginal Health Index |
3.9; 1.5; 5.0; 2.1; 5.2; 2.3 | <0.0001 sig |
| SECONDARY Change From Baseline in Vulvar Health Index |
-2.2; -1.4; -2.8; -1.7; -2.8; -1.6 | 0.0002 sig |
| SECONDARY Change From Baseline in Vulvovaginal Imaging Total Score at Week 12 |
-1.1; -0.1 | 0.0118 sig |
| SECONDARY Change From Baseline in Female Sexual Function Index Total Score |
4.13; 4.11; 4.70; 4.51; 5.71; 4.13 | 0.9748 |
| SECONDARY Change From Baseline in Female Sexual Function Index Domain Scores at Week 12 |
0.56; 0.39; 0.64; 0.44; 1.29; 0.89 | 0.0752 |
| SECONDARY Change From Baseline in Urinary Distress Inventory (UDI)-6 Total Score |
-0.8; -0.9; -1.0; -1.4; -1.3; -1.6 | 0.7230 |
| SECONDARY Change From Baseline in Bone Sialoprotein at Week 12 |
-24964.3; -20576.1 | 0.4263 |
| SECONDARY Change From Baseline in Type I Collagen C-Telopeptide (CTX) at Week 12 |
-0.044; 0.006 | <0.0001 sig |
| SECONDARY Change From Baseline in Deoxypyridinoline at Week 12 |
0.08; 0.22 | 0.5159 |
| SECONDARY Change From Baseline in Type I Collagen N-Telopeptide (NTX) at Week 12 |
-0.10; 0.65 | 0.0227 sig |
| SECONDARY Change From Baseline in Tartrate-Resistant Acid Phosphatase 5b at Week 12 |
-0.28; -0.06 | 0.0003 sig |
| SECONDARY Change From Baseline in Alkaline Phosphatase at Week 12 |
-4.6; 1.6 | <0.0001 sig |
| SECONDARY Change From Baseline in Bone-specific Alkaline Phosphatase at Week 12 |
-0.50; 0.84 | 0.0084 sig |
| SECONDARY Change From Baseline in Osteocalcin at Week 12 |
-1.43; 0.62 | <0.0001 sig |
| SECONDARY Change From Baseline in Procollagen 1 N-Terminal Propeptide (P1NP) at Week 12 |
-3.22; 2.04 | <0.0001 sig |
| SECONDARY Mean Days of Lubricant Use Per Week |
0.8; 0.8 | 0.9575 |
| SECONDARY Mean Days of Intercourse Per Week |
0.9; 0.9 | 0.8772 |
| SECONDARY Overall Satisfaction With Treatment at Week 12 |
83; 54; 71; 52; 43; 49 | 0.0007 sig |
| SECONDARY Change From Baseline in Estradiol at Week 12 |
-2.5; 0.5 | — |
| SECONDARY Change From Baseline in Follicle-Stimulating Hormone at Week 12 |
-5.18; -1.96 | — |
| SECONDARY Change From Baseline in Luteinizing Hormone at Week 12 |
-1.58; -0.38 | — |
| SECONDARY Change From Baseline in Sex Hormone-Binding Globulin at Week 12 |
30.44; 1.73 | — |
| SECONDARY Change From Baseline in Testosterone at Week 12 |
1.1; 1.2 | — |
| SECONDARY Change From Baseline in Free Testosterone at Week 12 |
0.0000; 0.0007 | — |
Summary
The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.
Eligibility Criteria
Inclusion Criteria
- Subject is postmenopausal.
- Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.
Exclusion Criteria
- Subject has clinically significant abnormal findings in the physical examination.
- Subject has a body mass index (BMI) equal to or greater than 38 kg/m^2
- Subject has uncontrolled hypertension.
- Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy.
- Subject has uterine/vaginal bleeding of unknown origin.
- Subject has a vaginal infection requiring medication (may be treated and be eligible for study).
Data sourced from ClinicalTrials.gov (NCT02638337). 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.