Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ethinylestradiol/Gestodene · 5 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) | DRUG | 0.55mg ethinylestradiol and 2.1mg gestodene |
| Norelgestromin/Ethinylestradiol (EVRA) | DRUG | 0.6mg ethinylestradiol and 6mg norelgestromin |
| Ethinylestradiol/Gestodene (BAY86-5016) | DRUG | 7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen |
| Ethinylestradiol/Gestogene (BAY86-5016) | DRUG | 7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen |
Inclusion Criteria: * Healthy women requesting contraception aged 18-35 years old * Smokers must not be older than 30 at time of informed consent * History of regular cyclic menstrual periods, normal cervical smear Exclusion Criteria: * Pregnancy or lactation * Obesity (BMI\>30), hypersensitivity...
Ethinylestradiol/Gestodene is a small molecule combination product being developed for contraception. It pairs ethinylestradiol with gestodene and is delivered as a transdermal contraceptive patch. Bayer AG is developing it, and it has been studied in Phase 3 clinical trials.
Ethinylestradiol/Gestodene is used for contraception. Clinical trials have evaluated it for preventing pregnancy, with additional studies examining ovulation inhibition and endometrial effects. The product is a transdermal patch rather than an oral tablet.
Ethinylestradiol/Gestodene works by targeting ESR1, the estrogen receptor, as an agonist. Ethinylestradiol activates this receptor, while gestodene is a progestin component. Together they act on the endocrine system to inhibit ovulation and support contraceptive efficacy.
Bayer AG is developing Ethinylestradiol/Gestodene. The company trades on the OTC market under the ticker BAYRY. Bayer has sponsored the clinical trial program for this transdermal contraceptive patch.
Ethinylestradiol/Gestodene is in Phase 3 development. It is investigational and has not been approved by the FDA. Five clinical trials have been completed, including Phase 2 and Phase 3 studies, with no active trials currently listed.
Ethinylestradiol/Gestodene has been studied in five completed trials. These include NCT00984789, a Phase 3 birth control patch study; NCT00914693, a Phase 3 Pearl Index study; and NCT00915915 and NCT00896571, both Phase 2 studies. Total enrollment across the program was 2,460 participants.
Ethinylestradiol/Gestodene is also known by several alternative names, including BAY86-5016 and FC Patch Low BAY86-5016. Other listed names such as Miranova and Yarina refer to different ethinyl estradiol combinations, with levonorgestrel and drospirenone respectively, so they are not the same product.