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Label indication RIVELSA ® is indicated for use by females of reproductive age to prevent pregnancy. RIVELSA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) FDA label
Also known as Quartette®
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 being developed for breakthrough bleeding. It is a small molecule therapeutic candidate studied in a Phase 2 clinical trial that evaluated bleeding patterns in women. Breakthrough bleeding refers to unscheduled bleeding that can occur between expected menstrual periods.
DR-1031 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program studying DR-1031 for breakthrough bleeding.
DR-1031 is in Phase 2 clinical development. The program includes one completed Phase 2 trial, and no active trials are currently listed. DR-1031 is investigational and has not been approved by the FDA for any indication.
DR-1031 has been studied in one completed Phase 2 trial, NCT00394771, titled A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale. The trial enrolled 567 female participants aged 18 years and older in the United States and was randomized, double-blind, and active-controlled.
DR-1031 is not FDA approved. It is an investigational small molecule in Phase 2 clinical development for breakthrough bleeding, and its only listed trial, NCT00394771, has completed.