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DR-2041a · 1 trial · 1 indication
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...
DR-2041a is an investigational small molecule being developed for the treatment of menopause. It is specifically being studied for vulvovaginal atrophy, a condition associated with menopause. The drug is in Phase 3 clinical development and is not yet approved by regulatory authorities.
DR-2041a is a synthetic conjugated estrogen, a type of estrogen therapy. It works by replacing declining estrogen levels in postmenopausal women, which helps alleviate symptoms of vulvovaginal atrophy such as vaginal dryness and irritation. The drug is designed to restore the health of vaginal tissues.
DR-2041a is being developed by Teva Pharmaceutical Industries Limited, a global pharmaceutical company. Teva is listed on the stock exchange under the ticker symbol TEVA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for menopause-related vulvovaginal atrophy.
DR-2041a is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not been approved by the FDA or other regulatory agencies. Further development and regulatory review are required before it can be marketed.
DR-2041a has been studied in one completed Phase 3 clinical trial with the identifier NCT00361569. This trial evaluated the safety and efficacy of DR-2041 (synthetic conjugated estrogens, A) for the treatment of vulvovaginal atrophy in 622 postmenopausal women in the United States. The trial was randomized, double-blind, and placebo-controlled.
DR-2041a is closely related to DR-2041, which is the name used in the clinical trial NCT00361569. The trial evaluated DR-2041, described as synthetic conjugated estrogens, A. DR-2041a appears to be an alternative designation for the same investigational drug being developed by Teva for menopause-related vulvovaginal atrophy.