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Also known as BAY 86-5310 (ZK 283197)
BAY 86-5310 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ZK 283197, 3 mg | EXPERIMENTAL | Postmenopausal women with hot flushes received 3 mg (3 x 1 mg tablets) ZK 283197, administered orally once daily over 8 weeks |
| Matching placebo | PLACEBO_COMPARATOR | Postmenopausal women with hot flushes received placebo (3 tablets) orally once daily over 8 weeks |
| ZK 283197, 2 mg | EXPERIMENTAL | Postmenopausal women with hot flushes received 2 mg (2 x 1 mg tablet) ZK 283197 plus 1 placebo tablet, once daily orally over 8 weeks |
| 17ß-estradiol | ACTIVE_COMPARATOR | Postmenopausal women with hot flushes received 1 mg (2 x 0.5 mg tablet) 17ß-estradiol plus 1 placebo tablet, once daily orally over 8 weeks |
| Name | Type | Description |
|---|---|---|
| BAY 86-5310 (ZK 283197) | DRUG | 3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks |
| Placebo | DRUG | Placebo, once daily p.o. over 8 weeks |
| 17ß-estradiol | DRUG | 1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks |
Inclusion Criteria: * Women with at least 35 moderate to severe hot flushes in seven consecutive days * Body mass index (BMI) : 20 - 30 kg/m² (inclusive) * Postmenopausal status Exclusion Criteria: * Contraindication for use for hormonal therapy * Prior hysterectomy * Hormonal therapy or intraute...
BAY 86-5310 is an investigational small molecule developed by Bayer AG for vasomotor symptoms, a condition within the neurology therapeutic area. It has completed a Phase 2 clinical trial and is not approved for any indication.
BAY 86-5310 is being studied for the treatment of vasomotor symptoms. It is an investigational therapy and has not been approved for any use.
BAY 86-5310 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY.
BAY 86-5310 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed.
BAY 86-5310 has been evaluated in a single completed Phase 2 trial, NCT00537836, titled ZK283197 for Treatment of Vasomotor Symptoms. The randomized, double-blind, placebo-controlled study enrolled 116 female participants aged 45 years and older in Germany, the Netherlands, and the United Kingdom.
Yes, BAY 86-5310 is also known as ZK 283197. Both names refer to the same investigational compound developed by Bayer AG for vasomotor symptoms.