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Dienogest · 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 also studied for its pharmacodynamic effects. The drug is currently in Phase 3 clinical development, with completed trials in patients with endometriosis, including a study in Chinese patients.
Dienogest is a synthetic progestin, a type of hormone that acts on progesterone receptors. It is used to treat endometriosis by suppressing the growth of endometrial tissue. The drug's mechanism involves its progestogenic activity, which helps reduce the symptoms associated with endometriosis.
Dienogest is developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The company has conducted multiple clinical trials to evaluate the safety and efficacy of Dienogest for endometriosis.
Dienogest is in Phase 3 clinical development for the treatment of endometriosis. It has completed Phase 1, Phase 2, and Phase 3 trials. The drug is investigational and not yet approved by regulatory authorities. All completed trials have been finalized, with no active trials currently ongoing.
Dienogest has been studied in three completed clinical trials. NCT00754871 was a Phase 1 pharmacodynamic study in healthy volunteers in the Netherlands. NCT01283724 was a Phase 2 safety study in adolescents with endometriosis across Europe. NCT01822080 was a Phase 3 efficacy study in Chinese patients with endometriosis.
Yes, Dienogest is marketed under the brand name Visanne. The Phase 2 trial NCT01283724, titled 'Visanne Study to Assess Safety in Adolescents,' evaluated Dienogest in adolescents with endometriosis. This confirms that Visanne is a brand name for the drug Dienogest.