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Visanne · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Visanne (SH T00660AA , BAY86-5258) | DRUG | Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients |
| Visanne (BAY86-5258, SH T00660AA) | DRUG | orally once daily |
| Placebo | DRUG | orally once daily |
Inclusion Criteria: * Female patients with endometriosis-associated pelvic pain Exclusion Criteria: * Pregnant or lactating women * History or suspicion of hormone dependent tumor * Therapy resistant endometriosis or need for primary surgical treatment * Any other conditions which forbid the part...
Visanne is used for the treatment of endometriosis. It is a small molecule medicine developed by Bayer AG under the ticker BAYRY. The clinical program for Visanne studied the efficacy and safety of the drug in women with endometriosis, with trials enrolling adult female participants aged 18 years and older.
Visanne is made by Bayer AG, which trades under the ticker BAYRY. Bayer developed the compound and ran the Phase 3 clinical program evaluating it in endometriosis. The drug is also referenced in trial documentation under the code names BAY86-5258 and SH T00660AA.
Visanne has been studied in Phase 3 clinical development for endometriosis. Two Phase 3 trials have been completed, and no trials are currently active. The program enrolled a total of 366 participants across the two completed studies, both of which were randomized, double-blind, and placebo-controlled.
Visanne was evaluated in two completed Phase 3 trials. NCT00225199, titled Efficacy and Safety of SH T00660AA in Treatment of Endometriosis, enrolled 198 participants. NCT00225186, titled Safety and Efficacy of SH T00660AA in Treatment of Endometriosis, enrolled 168 participants and was conducted in Germany, Italy, and Ukraine. Both trials enrolled women aged 18 years and older.
Yes. Visanne is also known by the development codes BAY86-5258 and SH T00660AA. These names refer to the same Bayer compound studied in the Phase 3 endometriosis program, so searches for BAY86-5258 or SH T00660AA describe the same drug as Visanne.
Visanne was studied in two completed Phase 3 trials in endometriosis, both randomized, double-blind, and placebo-controlled. Together they enrolled 366 participants, all female and aged 18 years or older. NCT00225199 enrolled 198 participants, and NCT00225186 enrolled 168 participants across Germany, Italy, and Ukraine.