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Also known as Dienogest (81150037), Dienogest
Dienogest/ Visanne · 3 trials · 1 indication
Change in average daily VAS (in mm) endometriosis-related pelvic pain score (cyclic and non-cyclic, combined) during Treatment Period 6 (assessed at Visit 7) in comparison to Screening Cycle as reported in the participant's diary.
The measurement of BMD by DEXA is the gold standard method for investigation of bone mass.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Participants receive Indinol Forto 200 mg capsules orally twice a day during 24 weeks |
| Arm 2 | ACTIVE_COMPARATOR | Participants receive Visanne 2 mg tablets orally once a day during 24 weeks |
| Dienogest | EXPERIMENTAL | 50% of the participants will be randomized to this arm and will receive 2 mg dienogest (DNG) once daily by mouth from 0-52 weeks |
| Placebo | PLACEBO_COMPARATOR | 50% of the participants will be randomized to this arm and will receive placebo once daily by mouth from 0-24 weeks then switch to 2 mg dienogest (DNG) once daily by mouth from 25-52 weeks |
| Dienogest (Visanne, BAY86-5258) | EXPERIMENTAL | Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks. |
| Name | Type | Description |
|---|---|---|
| Indole-3-carbinol | DRUG | Indinol Forto (indolecarbinol (indole-3-carbinol)) 200 mg capsules orally twice a day during 24 weeks |
| Dienogest | DRUG | Visanne (dienogest) 2 mg tablets orally once a day during 24 weeks |
| Dienogest (Visanne, BAY86-5258) | DRUG | 2 mg dienogest (DNG) once daily by mouth |
| Placebo | DRUG | Matching placebo once daily by mouth |
Inclusion Criteria: 1. The participant provides written informed consent for participation in the study in accordance with current legislation. 2. Female participants in reproductive/premenopausal period from 18 to 45 years old inclusively (at the moment of signing informed consent). 3. Participant...
Dienogest, marketed as Visanne, is used for the treatment of endometriosis. It is a small molecule developed by Bayer AG. The clinical program includes Phase 3 and Phase 2 trials in women with endometriosis, with a total enrollment of 651 participants across completed and ongoing studies.
Dienogest/ Visanne is developed by Bayer AG, which trades under the ticker BAYRY. Bayer AG is the sponsor of the clinical trials evaluating the drug in endometriosis.
Dienogest/ Visanne is in Phase 3 development for endometriosis. The program includes a completed Phase 3 trial in Chinese patients and a recruiting Phase 3 trial comparing Indinol Forto 200 mg capsules with Visanne 2 mg tablets. A completed Phase 2 study assessed safety in adolescents.
Dienogest/ Visanne has been studied in three clinical trials: NCT01822080, a completed Phase 3 trial in Chinese patients with endometriosis; NCT01283724, a completed Phase 2 safety study in adolescents; and NCT07164183, a recruiting Phase 3 trial in Russia comparing Indinol Forto 200 mg capsules with Visanne 2 mg tablets.
Yes, Dienogest/ Visanne is also known as Dienogest (81150037), Dienogest, and Dienogest (Visanne, BAY86-5258). These alternative names refer to the same small molecule developed by Bayer AG for endometriosis.