Study Design. The Phase 3 study will be a randomized, double-blind, multicenter, placebo-controlled trial covering 1 [*] of observation, followed by randomization of qualified subjects to [*] months of treatment and a 1 [*] safety follow-up period. Two doses of ER 206323 will be studied. Patients will be postmenopausal women defined as being 45 years old or greater and having [*] months of spontaneous amenorrhea, or [*] months of spontaneous amenorrhea with serum FSH levels of > [*] IU/L, or as women who are [*]-weeks post-surgical oophorectomy. As for the Phase 2 study, hot flash frequency and severity will be established during a pretreatment period of observation and qualifying patients will be then eligible to enroll in the study. As before, the criterion for entry will be a frequency of [*]hot flashes per day or [*] to [*] hot flashes per [*]. Efficacy will be assessed as the reduction in frequency and severity of hot flashes compared to placebo. The estimated subject number and dose groups are outlined below: * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. It is estimated that the Phase 3 study will require about [*] subjects to provide adequate evidence of clinical safety for ER-306323. Since [*]doses of ER-306323 will be administered in this trial, there will be at least [*] patients available to provide endometrial safety data on this product. While powered beyond this need, the Phase 3 study will provide confirmatory evidence of efficacy for ER-306323. The [*] doses to be employed in the Phase 3 trial will include the [*] as identified in the Phase 2 study as well as [*] provide [*]. Efficacy will be based on difference in efficacy [*]. Endometrial safety will be based on self-reported vaginal bleeding, endometrial ultrasound and endometrial biopsy data. Endometrial biopsy data will be assessed according to objective common criteria by a panel of [*]pathologists in [*] independent medical institutions. The Phase 3 study will provide additional long-term safety information on serum lipids and on coagulation markers such as [*]. Influence of ethnicity on efficacy and safety will be assessed and drug-drug interaction effects will also be evaluated where appropriate. BMD will also be assessed at start and end of treatment and treatment effect will be compared to [*]. Markers of bone metabolism will also be assessed. Finally, overall clinical and laboratory safety will be assessed throughout the study.
Appears in 2 contracts
Sources: License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.)
Study Design. The Phase 3 study will be a randomized, double-blind, multicenter, placebo-controlled trial covering 1 [*] of observation, followed by randomization of qualified subjects to [*] 3 months of treatment and a 1 [*] safety follow-up period. Two doses of ER 206323 will be studied. Patients will be postmenopausal women defined as being 45 years old or greater and having [*] months of spontaneous amenorrhea, or [*] months of spontaneous amenorrhea with serum FSH levels of > [*] IU/L, or as women who are [*]-weeks post-surgical oophorectomy. As for the Phase 2 study, hot flash frequency and severity will be established during a pretreatment period of observation and qualifying patients will be then eligible to enroll in the study. As before, the criterion for entry will be a frequency of [*]hot flashes per day or [*] to [*] hot flashes per [*]. Efficacy will be assessed as the reduction in frequency and severity of hot flashes compared to placebo. The estimated subject number and dose groups are outlined below: * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. It is estimated that the Phase 3 study will require about [*] subjects to provide adequate evidence of clinical safety for ER-306323. Since [*]doses of ER-306323 will be administered in this trial, there will be at least [*] patients available to provide endometrial safety data on this product. While powered beyond this need, the Phase 3 study will provide confirmatory evidence of efficacy for ER-306323. The [*] doses to be employed in the Phase 3 trial will include the [*] as identified in the Phase 2 study as well as [*] provide [*]. Efficacy will be based on difference in efficacy [*]. Endometrial safety will be based on self-reported vaginal bleeding, endometrial ultrasound and endometrial biopsy data. Endometrial biopsy data will be assessed according to objective common criteria by a panel of [*]pathologists in [*] independent medical institutions. The Phase 3 study will provide additional long-term safety information on serum lipids and on coagulation markers such as [*]. Influence of ethnicity on efficacy and safety will be assessed and drug-drug interaction effects will also be evaluated where appropriate. BMD will also be assessed at start and end of treatment and treatment effect will be compared to [*]. Markers of bone metabolism will also be assessed. Finally, overall clinical and laboratory safety will be assessed throughout the study.
Appears in 1 contract