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Also known as Generic Estradiol Vaginal Cream USP, 0.01%
Generic Estradiol Vaginal USP, 0.01% · 1 trial · 1 indication
Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5.
| Arm | Type | Description |
|---|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | EXPERIMENTAL | Participants were to self-administer 2 grams (g) of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. |
| Estrace Vaginal Cream USP, 0.01% | ACTIVE_COMPARATOR | Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. |
| Vehicle Vaginal Cream | PLACEBO_COMPARATOR | Participants were to self-administer 2 g of vehicle vaginal cream once daily at approximately the same time of the day for 7 consecutive days. |
| Name | Type | Description |
|---|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | DRUG | Vaginal cream, generic formulation of the brand product. |
| Estrace® Vaginal Cream USP, 0.01% | DRUG | Vaginal cream, brand product. |
| Vehicle Vaginal Cream | DRUG | Vaginal cream, placebo. Has no active ingredient |
Inclusion Criteria: * Signed Informed Consent Form (ICF) that meets all criteria of current Food and Drug Administration (FDA) regulations. * Females aged 30-75 years inclusive who are postmenopausal, defined as follows: * At least 12 months of spontaneous amenorrhea or 6 months of spontaneous amen...
Generic Estradiol Vaginal USP, 0.01% is a small molecule in the endocrine therapeutic area being developed for atrophic vaginitis, a condition of the vagina linked to estrogen deficiency. It is a vaginal cream formulation. The program is in Phase 3 development, and the single listed trial has been completed.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of Generic Estradiol Vaginal USP, 0.01%. The company is listed as the sponsor of the Phase 3 study evaluating the product. Teva is the only developer named for this asset.
Generic Estradiol Vaginal USP, 0.01% is in Phase 3 development. It is an investigational product and is not approved. One Phase 3 trial has been completed, and no trials are currently active. The completed study enrolled 663 participants.
Generic Estradiol Vaginal USP, 0.01% has been studied in one Phase 3 trial, NCT03294538, titled a study to evaluate equivalence of estradiol vaginal cream 0.01% to Estrace Cream 0.01% in atrophic vaginitis. The trial is completed, enrolled 663 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States.
Yes. Generic Estradiol Vaginal USP, 0.01% is also known as Generic Estradiol Vaginal Cream USP, 0.01%. The two names refer to the same Teva product, a small molecule vaginal cream in Phase 3 development for atrophic vaginitis. Searches using either name point to the same asset.
The completed Phase 3 trial NCT03294538 enrolled female participants aged 30 years and older with atrophic vaginitis. It did not enroll healthy volunteers. The study was randomized, double blind, and placebo controlled, with 663 participants enrolled in the United States.