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DR-1031 · 1 trial · 1 indication
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
| Arm | Type | Description |
|---|---|---|
| Low Dose DR-1031 | EXPERIMENTAL | 42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. |
| Midrange Dose DR-1031 | EXPERIMENTAL | 21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. |
| High Dose DR-1031 | EXPERIMENTAL | 21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. |
| Seasonale | ACTIVE_COMPARATOR | 84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets. |
| Name | Type | Description |
|---|---|---|
| DR-1031 | DRUG | Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm. |
| Seasonale® | DRUG | 84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles. |
| Portia® | DRUG | Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication. |
Inclusion Criteria: * Premenopausal * Not pregnant or breastfeeding * Agree to use back-up non-hormonal contraception for study period Exclusion Criteria: * Any contraindication to the use of oral contraceptives * Pregnancy within the last 3 months * Smoking \>10 cigarettes per day
DR-1031 is an investigational small molecule being developed for breakthrough bleeding. It is a Phase 2 drug candidate studied in a clinical trial that evaluated bleeding patterns with three different doses of DR-1031 compared to Seasonale in healthy female volunteers aged 18 years and older.
The molecular target of DR-1031 has not been disclosed. The drug is a small molecule being studied for its effect on breakthrough bleeding, and the available clinical trial information does not specify a particular biological target or mechanism of action.
DR-1031 is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. The drug is currently in Phase 2 clinical development for the treatment of breakthrough bleeding.
DR-1031 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for breakthrough bleeding.
DR-1031 has been studied in one completed Phase 2 clinical trial with the identifier NCT00394771. This randomized, double-blind, active-controlled study enrolled 567 participants in the United States and evaluated bleeding patterns with three different doses of DR-1031 compared to Seasonale.
No, DR-1031 is not the same as Seasonale. DR-1031 is an investigational drug being studied for breakthrough bleeding, while Seasonale is a contraceptive used as an active comparator in the clinical trial. The study compared three different doses of DR-1031 against Seasonale to evaluate bleeding patterns.