Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gyno-Daktarin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| BAY98-7196 | EXPERIMENTAL | Investigate the pharmacokinetics effect of a vaginally administered antimycotic (miconazole) during the use of an intra-vaginal ring (IVR) releasing anastrozole (ATZ) and levonorgestrel (LNG) |
| Administered Antibiotic | EXPERIMENTAL | Investigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG |
| Administered Spermicide | EXPERIMENTAL | Investigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG |
| Tampons | EXPERIMENTAL | Investigate the pharmacokinetics effect of the concomitant use of tampons during the use of an IVR releasing ATZ and LNG; investigate the pharmacokinetics over an extended IVR wearing period of 35 days |
| Name | Type | Description |
|---|---|---|
| Anastrozole / Levonorgestrel (BAY98-7196) | DRUG | Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG |
| Gyno-Daktarin | DRUG | 400 mg miconazole nitrate per day for 3 consecutive days |
| Sobelin vaginal creme | DRUG | 100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days |
| Patentex oval | DRUG | 75 mg Nonoxynol-9 per day for 3 consecutive days |
| Tampon | OTHER | - |
Inclusion Criteria: * Healthy pre-menopausal female subject. * Age: 18 - 50 years (inclusive) at the first screening visit. For the subject \> 45 years follicle stimulating hormone (FSH) will be investigated at the second screening visit to confirm the pre-menopausal status (FSH \< 40 IU/L in serum...
Gyno-Daktarin is an investigational small molecule being studied for endometriosis, a condition where tissue similar to the uterine lining grows outside the uterus. It is currently in Phase 1 clinical development. The drug is not approved and remains under investigation for this indication.
Gyno-Daktarin is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker BAYRY. The company is conducting clinical research to evaluate the drug's potential in treating endometriosis.
Gyno-Daktarin is in Phase 1 clinical development. It is an investigational drug being studied for endometriosis. As of now, it has not received regulatory approval and is still undergoing clinical trials to assess its safety and pharmacokinetics.
Gyno-Daktarin has one completed Phase 1 trial, NCT02545452, which studied the effect of concomitant use of an antimycotic, antibiotic, spermicide, or tampons on the pharmacokinetics of anastrozole and levonorgestrel released from an intra-vaginal ring. The trial enrolled 52 female participants in Germany.
No, Gyno-Daktarin is not the same as anastrozole or levonorgestrel. In the clinical trial NCT02545452, Gyno-Daktarin was used as a concomitant medication to study its effect on the pharmacokinetics of anastrozole and levonorgestrel released from an intra-vaginal ring in healthy female volunteers.