CLINICAL TRIALS PROFILE FOR DROSPIRENONE; ESTETROL
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All Clinical Trials for drospirenone; estetrol
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02817828 ↗ | E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study | Completed | PRA Health Sciences | Phase 3 | 2016-06-01 | The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 18 to 50 years. |
| NCT02817828 ↗ | E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study | Completed | Estetra | Phase 3 | 2016-06-01 | The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 18 to 50 years. |
| NCT02817841 ↗ | E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study | Completed | PRA Health Sciences | Phase 3 | 2016-08-30 | The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years. |
| NCT02817841 ↗ | E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study | Completed | Estetra | Phase 3 | 2016-08-30 | The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years. |
| NCT02852681 ↗ | Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers | Completed | Estetra | Phase 1 | 2015-08-01 | This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period, two-sequence crossover study was conducted under medical supervision in 28 healthy female volunteers. |
| NCT02874248 ↗ | E4/DRSP Single and Multiple Dose PK and Early QT Study | Completed | Estetra | Phase 1 | 2016-05-01 | This study is conducted to evaluate the effect of single and multiple therapeutic and supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula (QTcF). |
| NCT02957630 ↗ | "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" | Completed | Estetra | Phase 1/Phase 2 | 2016-09-01 | The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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