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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 being developed for the treatment of vulvovaginal atrophy associated with menopause. It is a small molecule therapeutic candidate in the endocrine therapeutic area. The clinical program has focused on evaluating its safety and efficacy in women with this condition.
DR-2041a is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. The company is responsible for the clinical development of this small molecule candidate for menopause-related vulvovaginal atrophy.
DR-2041a is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
DR-2041a has been evaluated in a completed Phase 3 trial, NCT00361569, titled "A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy." The trial enrolled 622 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, DR-2041a is also known as synthetic conjugated estrogens, A. This alternative name appears in the title of its Phase 3 trial, NCT00361569, which evaluated the safety and efficacy of DR-2041 for the treatment of vulvovaginal atrophy associated with menopause.