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Also known as Gynodian® Depot (BAY86-5032)
Gynodian Depot · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Gynodian® Depot (BAY86-5032) | DRUG | Injection monthly |
| BAY86-4980 | DRUG | orally |
Inclusion Criteria: * Written informed consent * Postmenopausal status (amenorrhea for at least 12 months) * 45 - 65 years of age * Application of estrogen or cyclic estrogen/progestin preparation other than the study medication for at least 6 months prior to Visit 1 * Relevant impairment of well-b...
Gynodian Depot is an investigational small molecule developed by Bayer AG for hormone replacement therapy in women. It is also known as Gynodian® Depot (BAY86-5032). The drug has been studied in a Phase 3 clinical trial for women with impaired well-being.
Gynodian Depot is being developed for hormone replacement therapy. Its clinical program has focused on women with impaired well-being, a condition associated with hormonal changes. The drug is not yet approved and remains under clinical investigation.
Gynodian Depot is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical program for this hormone replacement therapy candidate.
Gynodian Depot is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.
Gynodian Depot has been evaluated in a single completed Phase 3 trial, NCT00463450, titled Efficacy of Gynodian® Depot in Women With Impaired Well-being. The trial enrolled 140 female participants aged 45 years and older and used a randomized, double-blind, active-controlled design.
Yes, Gynodian Depot is also known as Gynodian® Depot (BAY86-5032). BAY86-5032 is an internal Bayer code for the same investigational compound. Both names refer to the same hormone replacement therapy candidate developed by Bayer AG.