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Also known as Menostar (estradiol transdermal delivery system)
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 estradiol transdermal delivery system developed by Bayer AG for postmenopausal women. It is being studied for two indications: hot flashes and osteopenia, the loss of bone mineral density that can precede osteoporosis. Both uses target symptoms and conditions related to the decline in estrogen after menopause.
Menostar delivers estradiol, a small molecule form of estrogen, through the skin via a transdermal patch. By supplying estradiol systemically, it targets estrogen-responsive tissues involved in thermoregulation and bone turnover, which underlies its evaluation in hot flashes and osteopenia in postmenopausal women.
Menostar is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor responsible for the clinical development program evaluating the estradiol transdermal delivery system in postmenopausal women.
Menostar is in Phase 3 clinical development. It is investigational and has been studied in completed Phase 3 trials, including a 500-participant study in osteopenia and a 165-participant study in hot flashes. No active trials are currently listed for this program.
Menostar has been evaluated in two completed Phase 3 trials. NCT00310531 was a 3-year study comparing Menostar with Evista to prevent osteoporosis in postmenopausal women with osteopenia, enrolling 500 participants. NCT00185237 studied an ultra-low dose estradiol patch for hot flashes in Asian women, enrolling 165 participants.
Yes. Menostar is also known as the estradiol transdermal delivery system and by the development code BAY86-5435. These names refer to the same Bayer AG product, a small molecule estradiol patch being studied in Phase 3 for hot flashes and osteopenia in postmenopausal women.