Table 2.

Primary and secondary endpoints

Primary endpoint Change from baseline to 6 weeks for the HFSSS

Secondary endpoints 1. Change from baseline to 2, 4, 10, and 14 weeks for the HFSSS 2. Change from baseline to 2, 4, 6, 10, and 14 weeks for the frequency of hot flashes 3. Changes from baseline to 2, 4, 6, 10, and 14 weeks for the severity of hot flashes 4. The proportion of responders (at least a 50% reduction in the HFSSS) at 6, 10, and 14 weeks 5. Changes from baseline to 6, 10, and 14 weeks for the FACT-P 6. Changes from baseline to 6, 10, and 14 weeks for the IIEF-5 7. Changes from baseline to 6, 10, and 14 weeks for the SAS 8. Changes from baseline to 6, 10, and 14 weeks for the SDS