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 a combined oral contraceptive developed by Bayer AG. It pairs estradiol valerate with dienogest and is studied for contraception, heavy menstrual bleeding, and ovulation inhibition. It is a small molecule product in the endocrine therapeutic area and has been evaluated in six completed clinical trials with a total enrollment of 3,919 participants.
EV/DNG is used for contraception and for heavy menstrual bleeding, also called metrorrhagia. Its studied indications include oral contraception, ovulation inhibition, and prevention of unplanned pregnancy. Trials have also examined its effect on hormone-related symptoms such as pelvic pain and headache in women using oral contraceptives.
Bayer AG develops EV/DNG. Bayer trades on the OTC market under the ticker BAYRY. The company has sponsored the clinical trial program for this combined oral contraceptive, including Phase 2 and Phase 3 studies conducted across Europe, Asia, and other regions.
EV/DNG is in Phase 3 development. All six of its listed trials are completed, with no active trials currently recruiting. The program includes Phase 3 studies in contraception and heavy menstrual bleeding plus a Phase 2 ovulation inhibition study. It is an investigational product and is not described as FDA approved.
EV/DNG has been studied in six completed trials. These include NCT01638923 in heavy menstrual bleeding, NCT01638910 in contraception, NCT00805415 on ovulation inhibition, and NCT00778609 on hormone-related symptoms such as pelvic pain and headache. The trials were randomized, double-blind, and actively controlled, enrolling 3,919 participants in total.
Yes. EV/DNG is also known as Qlaira and Natazia, along with the code names BAY86-5027 and SH T00658ID. Qlaira and Natazia are the brand names for the same estradiol valerate and dienogest combination developed by Bayer AG, so searches for any of these names refer to the same product.