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Also known as Dienogest (81150037), Dienogest, Dienogest (Visanne, BAY86-5258)
Dienogest/ Visanne · 3 trials · 2 indications
The measurement of BMD by DEXA is the gold standard method for investigation of bone mass.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Arm 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dienogest (Visanne, BAY86-5258) | DRUG | 2 mg dienogest (DNG) once daily by mouth |
| Placebo | DRUG | Matching placebo once daily by mouth |
| Dienogest (81150037) | DRUG | daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days |
| Dienogest (81150231) | DRUG | daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days |
| Dienogest (SH T00660A) | DRUG | daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days |
| Dienogest (81150746) | DRUG | daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days |
Inclusion Criteria: * Women between 18 and 45 years of age, inclusive * Women with endometriosis confirmed by laparoscopy or laparotomy within ten years but no later than 2 weeks before the Screening Visit * A score of at least 30 on a 100 mm visual analog scale (VAS) for endometriosis-associated p...
Dienogest is a small molecule being developed by Bayer AG for the treatment of endometriosis. It is currently in Phase 3 clinical development for this indication, with a completed Phase 3 study in Chinese patients. The drug is also being studied for pharmacodynamics in healthy volunteers.
Dienogest is a synthetic progestin, a type of hormone that mimics the effects of natural progesterone. It works by suppressing ovarian function and reducing the growth of endometrial tissue, which helps alleviate the symptoms of endometriosis. Its mechanism involves binding to progesterone receptors and inhibiting ovulation.
Dienogest is developed by Bayer AG, a multinational pharmaceutical company. The company's stock is traded under the ticker symbol BAYRY. Bayer has conducted multiple clinical trials to evaluate the safety and efficacy of Dienogest for the treatment of endometriosis.
Dienogest is in Phase 3 clinical development for the treatment of endometriosis. A Phase 3 study, NCT01822080, has been completed in Chinese patients. The drug is not yet approved in the United States and remains investigational for this indication.
Dienogest has been studied in several clinical trials, including NCT01822080, a Phase 3 study for endometriosis in Chinese patients, and NCT01283724, a Phase 2 study to assess safety in adolescents with endometriosis. Additionally, NCT00754871 was a Phase 1 pharmacodynamic study in healthy volunteers.
Yes, Dienogest is the active ingredient in the brand-name medication Visanne. Visanne is a trade name for Dienogest, which is used for the treatment of endometriosis. The drug is marketed under this brand name in various countries, including those in Europe.