Phase 3
N=576
Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
Vulvovaginal Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT01816139 ↗Enrolled (actual)
576
Serious AEs
0.7%
Results posted
May 2022
Primary outcome: Primary: Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment — 2.5; 2.5; -1.2; -1.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vehicle (Drug); WC3011 Estradiol Vaginal Cream (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Warner Chilcott
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment |
2.5; 2.5; -1.2; -1.4 | — |
| PRIMARY Change From Baseline in Vaginal pH to Final Assessment |
6.33; 6.34; -0.31; -1.26 | — |
| PRIMARY Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment |
0.3; 0.4; 0.8; 8.6 | — |
| PRIMARY Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment |
46.5; 44.2; -4.4; -37.4 | — |
| SECONDARY Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12 |
2.5; 2.5; -0.9; -1.0; -1.1; -1.2 | — |
| SECONDARY Change From Baseline in Participants Self-Assessment of the Symptoms of VVA |
1.1; 1.1; -0.5; -0.5; -0.6; -0.6 | — |
| SECONDARY Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity |
18.5; 24.3; 8.4; 8.4; 6.1; 4.6 | — |
| SECONDARY Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment |
2.1; 2.0; -0.4; -0.7; -0.4; -0.7 | — |
| SECONDARY Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12 |
0.3; 0.4; 0.6; 9.3 | — |
| SECONDARY Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12 |
46.5; 44.2; -4.7; -38.7 | — |
Summary
The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Moderate to severe vaginal dryness
- Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with serum Follicle-stimulating hormone (FSH) > 40 milli-International Unit (mIU)/mL, 6 weeks postsurgical bilateral oophorectomy confirmed by surgical report, ultrasound or serum FSH > 40 mIU/mL, 6 weeks postsurgical hysterectomy with ovary failure confirmed by serum FSH > 40 mIU/mL
- Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
- Vaginal pH >5.0
- Less than or equal 5% superficial cells on vaginal wall cytologic smear
- Normal breast exam; if > 40 years, documentation of negative mammogram
Exclusion Criteria
- Randomization in PR-04409, participation in clinical trial or use of investigational drug within 30 days prior to screening
- Smokes ≥ 15 cigarettes/day
- Known or suspected premalignant or malignant disease
- Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure, stroke or ischemic attack, thrombophlebitis or thromboembolic disorder
- Increased frequency/severity headaches with estrogen therapy
- Drug addiction/alcohol abuse within last 2 years
- Currently taking St. John's Wort or anticoagulant
- Uncontrolled hypertension or thyroid disorder, clinically significant depression or untreated urinary tract infection
Data sourced from ClinicalTrials.gov (NCT01816139). 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.