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The results showed that ENDOMETRIN was efficacious, with no significant differences in efficacy parameters between treatment arms. Continuing pregnancy rates were 42.3 percent with ENDOMETRIN TID and 38.6 percent with ENDOMETRIN BID. The groups also showed equivalent tolerability, with no significant differences in the incidence of adverse events between groups.
Results in Harder-to-Treat Patients
The activity of ENDOMETRIN was also evaluated in harder-to-treat patients - women over age 35, or with elevated basal follicle stimulating hormone (FSH) or body mass index (BMI). Excellent continuing pregnancy rates were observed across a broad range of patient types with the use of BRAVELLE, MENOPUR and ENDOMETRIN.
Once-Daily Mixed Protocol
The trial data also demonstrated that administration of MENOPUR and BRAVELLE once a day as a single combined injection provided equal efficacy compared with twice-daily dosing, and that twice-daily dosing offers no additional patient benefits.
Parameter Bravelle+Menopur QD Bravelle+Menopur BID p-value
N=777 N=434
Age 32.5 34.0 <0.001
BMI 25.0 24.9 0.181
Duration 10.0 10.6
Oocytes 14.0
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