Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Estradiol valerate, Dienogest
Estradiol Valerate/ Levomefolate Calcium · 5 trials · 4 indications
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).
At least 6, up to 8 criteria to be met in complete response during 90-day period: no bleeding episodes(BE) \>7 days, no \>4 BE, no BE with blood loss (menstrual blood loss, MBL) ≥80 mL, no \>1 BE increase from baseline, no increase from baseline in individual patient's total number of bleeding days and total number of bleeding days not \>24 days. Additionally, for subjects included with prolonged bleeding: decrease between maximum duration during run-in and efficacy ≥2 days excessive bleeding: MBL associated with each episode decreased by ≥50% from average of qualifying episodes during run-in.
| Arm | Type | Description |
|---|---|---|
| Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | EXPERIMENTAL | Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles |
| Ethinyl estradiol, Levonorgestrel (Miranova) | ACTIVE_COMPARATOR | Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles |
| Ortho Tri-Cyclen Lo | ACTIVE_COMPARATOR | Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | EXPERIMENTAL | A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 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. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo to be taken orally daily. |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | DRUG | Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval |
| Ethinyl estradiol, Levonorgestrel (Miranova) | DRUG | Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval |
| Placebo Match to SH T00658ID | DRUG | Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. |
| Placebo Match to SH D593B | DRUG | Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. |
| Ortho Tri Cyclen Lo | DRUG | Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo |
| Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | DRUG | 1 pill per day taken orally over 7 cycles of 28 pills per cycle |
| Placebo | DRUG | 1 pill per day taken orally over 7 cycles of 28 pills per cycle |
| Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078) | DRUG | Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days |
| Estradiol Valerate (EV) (BAY86-4980) | DRUG | Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days |
| Levomefolate Calcium (BAY86-7660) | DRUG | Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days |
Inclusion Criteria: * Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of \>/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score * Age: 14 - 50 years (inclusive; smokers ...