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Ferring Reports on ENDOMETRIN Presentations at Pacific Coast,Reproductive Society Annual Meeting

he centers had the option of combining BRAVELLE and MENOPUR and administering it as one single daily injection, which was done for approximately one third of the patients (n=777). On the day of oocyte retrieval, patients were randomized to ENDOMETRIN 100 mg twice daily, ENDOMETRIN 100 mg three times daily, or an active control (progesterone vaginal gel (90 mg) QD)*. In the study, efficacy was measured by continuing pregnancy rates. An analysis was also conducted to evaluate once-daily compared with twice-daily dosing of gonadotropins during the stimulation phase.

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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