Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EV/DNG · 10 trials · 8 indications
Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).
Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).
| Arm | Type | Description |
|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID) | EXPERIMENTAL | Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles. |
| EE/LNG (Microgynon) + Placebo | ACTIVE_COMPARATOR | Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles. |
| Name | Type | Description |
|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | DRUG | Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days) |
| EV/DNG (Qlaira, Natazia, BAY86-5027) | DRUG | 2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each. |
| placebo | DRUG | Matching placebo to be taken orally daily for 7 cycles of 28 days each. |
| EV/DNG (Qlaira, BAY86-5027, SH T00658ID) | DRUG | Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose |
| Microgynon | DRUG | Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles. |
| Encapsulated Microgynon + Placebo | DRUG | Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo |
| EV/DNG (Qlaira, BAY86-5027, SH T00658K) | DRUG | 7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo |
| SH D 593 B (Miranova) | DRUG | 7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo |
| SH D01155E | DRUG | per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo |
| SH D00264A (Triquilar) | DRUG | 7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo |
| EV/DNG (SH T00658L) | DRUG | Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg |
Inclusion Criteria: * Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception * Smokers may not exceed 35 years of age Exclusion Criteria: * Pregnancy or lactation (delivery, abortion, or lactation wit...
EV/DNG is an investigational small molecule oral contraceptive being developed for contraception and the prevention of unplanned pregnancy. It is also studied for use in metrorrhagia and ovulation inhibition. The drug is a combined oral contraceptive containing estradiol valerate and dienogest, and it remains in clinical development.
EV/DNG is being developed by Bayer AG, a multinational pharmaceutical company headquartered in Germany. Bayer trades on the OTC market under the ticker symbol BAYRY. The company has conducted multiple clinical trials of EV/DNG for contraceptive indications across Europe and other regions.
EV/DNG is in Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials, including a large Phase 3 efficacy and safety study with 1,392 participants. The drug is investigational and has not been approved by regulatory authorities.
EV/DNG has been studied in six completed clinical trials with a total enrollment of 3,919 participants. Key trials include NCT00185224, a Phase 2 metabolism study in Germany; NCT00185289, a Phase 3 efficacy and safety study in Austria, Germany, and Spain; and NCT00778609, a Phase 3 study on hormone-related symptoms.
EV/DNG is a combined oral contraceptive containing estradiol valerate, an estrogen, and dienogest, a progestin. It works by inhibiting ovulation and altering the uterine lining to prevent pregnancy. The combination of these hormones provides effective contraception through multiple mechanisms of action.
EV/DNG is the same drug as SH T00658ID, which is the code name used in clinical trial records. A Phase 2 study, NCT00318799, compared SH T00658ID to a monophasic contraceptive containing ethinylestradiol and levonorgestrel to evaluate effects on hemostatic parameters.