Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gestodene/EE Patch · 6 trials · 1 indication
Estradiol levels \> 100pmol/L indicate some ovarian activity and progesterone levels \> 5nmol/L in subjects with estradiol levels \> 100pmol/L reflect ovulation or luteinized unruptured follicles.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Gestodene/EE Patch | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Gestodene/EE (FC Patch Low, BAY86-5016) | DRUG | 21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2 |
| Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A | DRUG | 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1 |
| Gestodene/EE Patch (BAY86-5016) | DRUG | 55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 13 cycles |
| EE/Levonorgestrel (Microgynon, BAY86-4977) | DRUG | 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles |
Inclusion Criteria: * Female subject requesting contraception * Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent * Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has...
Gestodene/EE Patch is an investigational contraceptive patch being developed by Bayer AG (BAYRY). It combines gestodene and ethinyl estradiol for use in contraception. The drug is currently in Phase 3 clinical development, though all six completed trials were in earlier phases.
Gestodene/EE Patch contains two small-molecule hormones: gestodene, a progestin, and ethinyl estradiol, an estrogen. These hormones work together to prevent ovulation and provide contraception. The patch delivers these hormones transdermally through the skin.
Gestodene/EE Patch is being developed by Bayer AG, a German pharmaceutical company traded as BAYRY on the OTC market. Bayer is conducting clinical trials for this contraceptive patch, which is currently in Phase 3 development.
Gestodene/EE Patch is in Phase 3 clinical development. While the overall program is Phase 3, all six completed trials were Phase 1 or Phase 2 studies. The drug is investigational and not yet approved for contraception.
Gestodene/EE Patch has completed six clinical trials, including NCT00933179, NCT01083264, NCT01204190, and NCT02550977. These studies evaluated metabolism, bioavailability, and ovulation inhibition in healthy women. All trials are completed, with no active trials currently ongoing.
Gestodene/EE Patch is a contraceptive patch that delivers gestodene and ethinyl estradiol through the skin. It is designed to prevent pregnancy by inhibiting ovulation. The drug is in Phase 3 development and is not yet approved for use.