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Menostar · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Menostar (estradiol transdermal delivery system) | DRUG | Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day) |
| Placebo | DRUG | Placebo patch |
| Menostar (Estradiol, BAY86-5435) | DRUG | Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day) |
| Raloxifene | DRUG | Raloxifene tbl. (60 mg/day) |
Inclusion Criteria: * Evidence of postmenopausal status Exclusion Criteria: * Contraindication to estrogen therapy
Menostar is an investigational ultra-low dose estradiol patch being studied for the treatment of hot flashes and osteopenia in post-menopausal women. It is a small molecule endocrine therapy developed by Bayer AG. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
Menostar is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting Phase 3 clinical trials to evaluate the safety and efficacy of Menostar for treating hot flashes and osteopenia.
Menostar is currently in Phase 3 clinical development. Two Phase 3 trials have been completed: one studying its effect on hot flashes in Asian women and another comparing it to Evista for preventing osteoporosis in post-menopausal women with osteopenia. Menostar remains investigational and has not received FDA approval.
Menostar has been studied in two completed Phase 3 clinical trials. The first, NCT00185237, enrolled 165 women aged 45 and older to evaluate the treatment of hot flushes in Asian women. The second, NCT00310531, enrolled 500 women aged 55 and older in a 3-year study comparing Menostar to Evista for preventing osteoporosis.
Menostar is an ultra-low dose estradiol patch, a form of estrogen replacement therapy. It works by delivering estradiol through the skin to supplement declining estrogen levels in post-menopausal women, which may help alleviate hot flashes and prevent bone loss associated with osteopenia.