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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 being developed for contraception in women. It is a transdermal contraceptive patch that delivers two hormones through the skin. Bayer AG is developing it as a once-weekly or similar patch option for pregnancy prevention, and it has been studied in Phase 3 clinical trials.
Gestodene/EE Patch targets the progesterone receptor (PGR) as an agonist. Gestodene is a progestin that binds and activates PGR, while ethinyl estradiol (EE) provides estrogenic activity. Together they suppress ovulation and thicken cervical mucus, which are the primary contraceptive mechanisms of combined hormonal contraceptives.
Bayer AG is developing Gestodene/EE Patch. Bayer trades on the OTC market under the ticker BAYRY. The company has completed multiple clinical trials of the patch, including Phase 3 studies, as part of its contraceptive development program.
Gestodene/EE Patch is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. Bayer AG has completed six clinical trials of the patch, with no active trials currently listed.
Gestodene/EE Patch has been studied in six completed clinical trials. These include NCT02550977, a Phase 2 ovarian activity suppression study in Russia and Ukraine; NCT01204190, a Phase 2 ovulation inhibition study in Germany and the Netherlands; NCT01083264, a Phase 1 bioavailability study in Germany; and NCT00933179, a Phase 2 metabolism study in Germany.
Yes, Gestodene/EE Patch is also known as BAY86-5016 and Gestodene/EE (FC Patch Low). These are alternative names for the same investigational contraceptive patch developed by Bayer AG. The patch combines gestodene and ethinyl estradiol and has been evaluated in clinical trials for contraception.