Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Microgynon · 2 trials · 2 indications
Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)
| Arm | Type | Description |
|---|---|---|
| Arm1 | EXPERIMENTAL | single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) |
| Arm2 | EXPERIMENTAL | multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment, a single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) |
| Arm 1 | EXPERIMENTAL | Healthy premenopausal subjects will receive multiple oral doses of Microgynon for 21days |
| Arm 2 | EXPERIMENTAL | Healthy premenopausal subjects will receive a single intramuscular dose of Noristerat |
| Name | Type | Description |
|---|---|---|
| Microgynon | DRUG | single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) |
| Riociguat (Adempas,BAY63-2521) | DRUG | multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment |
| Noristerat(BAY86-6308) | DRUG | Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate. |
Inclusion Criteria: * Healthy female subject * Non-smokers of at least 3 month before screening * Age: 52 to 65 years (inclusive) at the first screening examination * Ethnicity: white * Body mass index (BMI)\>=20 and \<=32 kg/m2 * Postmenopausal state, defined as * Medical history, if applicable (n...
Microgynon is an investigational small molecule being studied for drug interactions and pharmacokinetics. It is developed by Bayer AG. In clinical trials, it has been evaluated in healthy postmenopausal women and healthy female volunteers to assess its effects and how it is processed in the body.
Bayer AG (ticker: BAYRY) is the developer of Microgynon. The company is conducting clinical research on this investigational drug, focusing on its pharmacokinetics and potential drug interactions.
Microgynon is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved for any medical use. All completed trials for Microgynon are Phase 1 studies.
Microgynon has been studied in two completed Phase 1 trials. NCT02159326 examined drug interactions in healthy postmenopausal women, and NCT02170038 investigated the conversion of norethisterone to ethinylestradiol in healthy female volunteers. Both trials were conducted in Germany.
Microgynon is a small molecule drug being studied for its pharmacokinetic properties. In one clinical trial, researchers investigated how the contraceptive compound norethisterone is converted within the body to ethinylestradiol, but Microgynon itself is the drug under investigation.