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This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estradiol Vaginal Capsule 0.003 mg | Experimental | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
|
| Estradiol Vaginal Capsule 0.01 mg | Experimental | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
|
| Estradiol Vaginal Capsule 0.02 mg | Experimental | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
|
| Placebo | Placebo Comparator | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol Vaginal Capsule (EVC) | Drug | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. | Baseline (Week 0) to Final Visit (Week 6) |
| Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vilma Sniukiene, MD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visions Clinical Research-Tucson | Tucson | Arizona | 85712 | United States | ||
| Genesis Center for Clinical Research |
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| Placebo | Drug | Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks |
|
Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. |
| Baseline (Week 0) to Final Visit (Week 6) |
| Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. | Baseline (Week 0) to Final Visit (Week 6) |
| Change in subject's self-assessment of dysuria | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. | Baseline (Week 0) to Final Visit (Week 6) |
| Change in subject's self-assessment of vaginal and/or vulvar irritation/itching | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. | Baseline (Week 0) to Final Visit (Week 6) |
| Change in subject's self-assessment of vaginal dryness in patients where vaginal dryness was not reported as the most bothersome symptom | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. | Baseline (Week 0) to Final Visit (Week 6) |
| Change in subject's self-assessment of dyspareunia in patients where dyspareunia was not reported as the most bothersome symptom | Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3. | Baseline (Week 0) to Final Visit (Week 6) |
| Self-assessment by sexually active participants as to the presence or absence of vaginal bleeding | Total number of participants who were sexually active assessed if vaginal bleeding was present or absent. | Baseline (Week 0) to Final Visit (Week 6) |
| San Diego |
| California |
| 92103 |
| United States |
| Coastal Connecticut Research, LLC | New London | Connecticut | 06320 | United States |
| Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | United States |
| Radiant Research, Inc. | Pinellas Park | Florida | 33781 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| Fellows Research Alliance, Inc | Savannah | Georgia | 31406 | United States |
| Beyer Research | Kalamazoo | Michigan | 49009 | United States |
| Office of R. Garn Mabey, M.D. | Las Vegas | Nevada | 89128 | United States |
| Carolina Women's Research and Wellness Center | Durham | North Carolina | 27713 | United States |
| Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Rapid Medical Research, Inc. | Cleveland | Ohio | 44122 | United States |
| Women's Health Research | Columbus | Ohio | 43213 | United States |
| Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| Fellows Research Alliance, Inc | Bluffton | South Carolina | 29910 | United States |
| Radiant Research, Inc. | Dallas | Texas | 75231 | United States |
| Radiant Research, Inc. | San Antonio | Texas | 78229 | United States |
| Virginia Women's Center | Richmond | Virginia | 23233 | United States |
| Seattle Women's Health, Research, Gynecology | Seattle | Washington | 98105 | United States |
| North Spokane Women's Clinic | Spokane | Washington | 99207 | United States |
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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