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Ortho Tri Cyclen Lo · 1 trial · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | EXPERIMENTAL | Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) |
| 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) |
| Name | Type | Description |
|---|---|---|
| Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | DRUG | Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 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 |
| 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 |
Inclusion Criteria: * Signed and dated informed consent * Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1 * Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC...
Ortho Tri Cyclen Lo is a small molecule drug used for contraception. It is an investigational oral contraceptive being developed by Bayer AG. The drug is currently in Phase 3 clinical development, with one completed Phase 3 trial that enrolled 409 healthy female participants aged 18 years and older.
Ortho Tri Cyclen Lo is developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is being studied for use in contraception and is currently in Phase 3 clinical development. Bayer has conducted one completed Phase 3 trial for this drug.
Ortho Tri Cyclen Lo is in Phase 3 clinical development. It is an investigational drug for contraception and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under investigation by its developer, Bayer AG.
Ortho Tri Cyclen Lo has one completed Phase 3 clinical trial, NCT00754065, titled "To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)". This randomized, double-blind, active-controlled trial enrolled 409 healthy female participants in the United States and Canada for the condition of contraception.
Ortho Tri Cyclen Lo is being compared to SH T00658ID in a Phase 3 clinical trial. The trial NCT00754065 is designed to compare the two drugs for contraception. Ortho Tri Cyclen Lo is developed by Bayer AG and is currently in Phase 3 clinical development.