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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00361569 | A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy | PHASE3 | COMPLETED | 622 | — | — | Aug 1, 2006 | Sep 1, 2007 | Apr 20, 2015 | 97 | United States |
Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.
Change= Week 12 vaginal pH - Baseline vaginal pH
Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells \* 0) + (% Intermediate Cells \* 0.5) + (% Superficial Cells \* 1.0)
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| 4 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DR-2041a | DRUG | 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter |
| DR-2041b | DRUG | 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter |
| Placebo | OTHER | 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter |
Inclusion Criteria: * Naturally or surgically menopausal * Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse) Exclusion Criteria: * Known sensitivity or contraindication to estrogens or progestins * History or current diagnosis endometrial hyper...