Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00431132 | Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis | PHASE3 | COMPLETED | 336 | — | — | Jan 1, 2007 | Nov 1, 2008 | Mar 15, 2017 | 42 | Czechia, Denmark +5 |
| NCT00108849 | Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms | PHASE3 | COMPLETED | 309 | — | — | Mar 1, 2005 | May 1, 2007 | Feb 8, 2017 | 57 | United States, Canada |
| NCT00464971 | Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial | PHASE3 | COMPLETED | 102 | — | — | Jan 31, 1995 | Nov 30, 1996 | Mar 1, 2017 | - | — |
| NCT00465192 | Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis | PHASE3 | COMPLETED | 230 | — | — | Aug 31, 1994 | Nov 30, 1995 | Mar 1, 2017 | - | — |
| NCT01085877 | Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis | PHASE1 | COMPLETED | 70 | — | — | Mar 1, 2010 | May 1, 2010 | Jun 26, 2014 | 1 | Germany |
| NCT01486979 | Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis | PHASE1 | COMPLETED | 58 | — | — | Jan 1, 2007 | May 1, 2007 | Feb 8, 2017 | 1 | Germany |
The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.
| Arm | Type | Description |
|---|---|---|
| Vagifem® 10 mcg | EXPERIMENTAL | One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks |
| Trial part 1 | ACTIVE_COMPARATOR | - |
| Trial part 2 | EXPERIMENTAL | - |
| Low dose | EXPERIMENTAL | - |
| High dose | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| estradiol, 10 mcg | DRUG | Tablets, administered intravaginally twice weekly |
| estradiol, 25 mcg | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: * Postmenopausal women whose last menstruation was at least two years prior to the time of screening * At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual act...