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ARTICLE | Clinical News

Mithra's Donesta meets in Phase II for postmenopausal vasomotor symptoms

May 4, 2018 3:51 PM UTC

Mithra Pharmaceuticals S.A. (Euronext:MITRA) reported data from the Phase II E4 Relief trial to treat vasomotor symptoms in postmenopausal women showing that once-daily 15 mg oral Donesta met the primary endpoint of reducing the frequency of moderate to severe vasomotor symptoms from baseline to week 12 vs. placebo (80% vs. 60%, p<0.05). Mithra said a high placebo effect is well-documented in vasomotor symptoms trials. The 15 mg dose of Donesta, which was determined to be the optimal oral minimum dose for the effective treatment of vasomotor symptoms, also significantly improved vaginal maturation index score vs. placebo (p<0.001).

The double-blind, European trial enrolled 257 postmenopausal women ages 40-65 to receive placebo or once-daily 2.5, 5, 10 or 15 mg oral Donesta for 12 weeks. Non-hysterectomized women also received progestin therapy for two weeks as a protective measure to control endometrial growth...

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Mithra Pharmaceuticals S.A.