Dyspareunia, Menopause, Vulvovaginal Atrophy
Conditions
Brief summary
This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
Interventions
DRUGEstradiol Vaginal Capsule (EVC)
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
DRUGPlacebo
Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of vulvovaginal atrophy due to post menopause * Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years * Moderate to severe vaginal dryness * Normal breast exam; if \> 40 years * Vaginal pH \> 5.0 * \< 5% superficial cells on vaginal wall cytology smear
Exclusion criteria
* Known hypersensitivity to estrogen and/or progestin therapy * Known or suspected premalignant or malignant disease * Undiagnosed abnormal genital bleeding * A history of or treatment for significant cardiovascular disease, congestive heart failure, or stroke * Active or known protein C, protein S, or antithrombin deficient, or other known thrombophilic disorders or thromboembolic events * Increased frequency/severity headaches with estrogen therapy * Smokes ≥ 15 cigarettes/day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the percentage of vaginal superficial cells | Baseline (Week 0) to Final Visit (Week 6) |
| Change in the percentage of vaginal parabasal cells | Baseline (Week 0) to Final Visit (Week 6) |
| Change in vaginal pH | Baseline (Week 0) to Final Visit (Week 6) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in subject's self-assessment of dysuria | Baseline (Week 0) to Final Visit (Week 6) | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. |
| Change in subject's self-assessment of vaginal and/or vulvar irritation/itching | Baseline (Week 0) to Final Visit (Week 6) | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. |
| Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale | Baseline (Week 0) to Final Visit (Week 6) | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. |
| Change in subject's self-assessment of dyspareunia in patients where dyspareunia was not reported as the most bothersome symptom | Baseline (Week 0) to Final Visit (Week 6) | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. |
| Self-assessment by sexually active participants as to the presence or absence of vaginal bleeding | Baseline (Week 0) to Final Visit (Week 6) | Total number of participants who were sexually active assessed if vaginal bleeding was present or absent. |
| Change in subject's self-assessment of vaginal dryness in patients where vaginal dryness was not reported as the most bothersome symptom | Baseline (Week 0) to Final Visit (Week 6) | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. |
| Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom | Baseline (Week 0) to Final Visit (Week 6) | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. |
| Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom | Baseline (Week 0) to Final Visit (Week 6) | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. |
Countries
United States
Outcome results
None listed