Phase 3
N=550
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
Vulvovaginal Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT01845649 ↗Enrolled (actual)
550
Serious AEs
0.7%
Results posted
May 2022
Primary outcome: Primary: Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment — 2.7; 2.7; -1.2; -1.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- WC3011 Estradiol Vaginal Cream (Drug); Vehicle (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 Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment |
2.7; 2.7; -1.2; -1.5 | — |
| PRIMARY Change From Baseline in Vaginal pH to Final Assessment |
6.35; 6.37; -0.53; -1.36 | — |
| PRIMARY Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment |
0.2; 0.2; 1.4; 10.1 | — |
| PRIMARY Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment |
50.6; 53.5; -14.6; -48.5 | — |
| SECONDARY Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12 |
2.7; 2.7; -0.8; -0.8; -1.1; -1.2 | — |
| SECONDARY Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment |
0.9; 1.0; -0.3; -0.3; -0.5; -0.3 | — |
| SECONDARY Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit |
27.0; 28.0; 15.9; 16.4; 7.9; 7.2 | — |
| SECONDARY Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment |
2.0; 2.0; -0.5; -0.9; -0.5; -0.9 | — |
| SECONDARY Change From Baseline in Vaginal pH to Week 12 |
6.35; 6.37; -0.53; -1.35 | — |
| SECONDARY Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12 |
0.2; 0.2; 1.2; 10.5 | — |
| SECONDARY Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12 |
50.6; 53.5; -14.9; -48.2 | — |
Summary
The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.
Eligibility Criteria
Inclusion Criteria
- Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)
- Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) >40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH >40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH >40 mIU/mL
- Age ≥40 years; ≥35 with bilateral oophorectomy
- Vaginal pH >5.0
- Less than or equal to 5% superficial cells on vaginal wall cytologic smear
- Normal clinical breast exam or negative mammogram if ≥ 40 years of age
- Negative urine pregnancy test (non-hysterectomized and 50% angiographic narrowing of coronary artery
- Thrombophlebitis or thromboembolic disorder or history of
- Insulin-dependent diabetes mellitus
- Increased frequency or severity of headaches while on hormone or estrogen therapy
- Currently taking St. John's Wort
- Drug/alcohol addiction within past 2 years
- Treatment with anticoagulants (heparin or warfarin)
- Smoking ≥15 cigarettes/day
Data sourced from ClinicalTrials.gov (NCT01845649). 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.