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PHILADELPHIA -- Menopausal symptoms improved with the investigational bioidentical hormone, TX-001HR, researchers reported here.

More menopausal women taking the combination 17β-estradiol and progesterone (E2/P4) oral treatment reported significantly reduced vasomotor symptoms after 4 weeks at any dose compared with placebo (46%-59% versus 33%; all P<0.05), according to Ginger Constantine, MD, of EndoRheum Consultants in Malvern, Pennsylvania, and colleagues.

A greater number of women also had a similar improvement at any dose of treatment after 12 weeks versus placebo (68%-73% versus 52%, P<0.05 for all), the researchers reported at the North American Menopause Society meeting.

The substudy of the phase III REPLENISH trial assessed vasomotor symptom efficacy in 726 women menopausal women, ages 40 to 65 (mean age 55) with an intact uterus. All women were experiencing moderate-to-severe vasomotor symptoms, including hot flashes seven or more times per day or at least 50 times per week.

They were randomized into one of four treatment arms of variable doses of the daily, single soft gel capsule -- E2/P4 at 1.0 mg/100 mg (n=141), 0.5 mg/100 mg (n=149), 0.5 mg/50 mg (n=147), 0.25 mg/50 mg (n=154), or placebo (n=135).

Assessed separately were four treatment groups at the same dosing strengths (1.0 mg/100 mg of E2/P4; 0.5 mg/100 mg; 0.5 mg/50 mg; and 0.25 mg/50 mg) to measure the trials' primary safe endpoint for endometrial hyperplasia.

In a self-reported assessment of vasomotor symptoms based upon the 7-level Clinical Global Impression scale, more menopausal women on oral treatment reported a "clinically meaningful" response to treatment, marked by a rating of "much improved" or "very much improved" in regards to vasomotor symptoms after 4 weeks (50%-63% versus 33%, P<0.01 for all). Responses for CGI were evaluated at weeks 4, 8 and 12 of the trial.

After 12 weeks, more women on any dose of treatment also reported a "clinically meaningful" self-reported response to TX-001HR (73%-82% versus 53%, P<0.01 for all). However, the highest dose treatment group experienced the most significant improvement in self-reported symptoms, although all doses reported significant improvements.

In a nonparametric discriminant analyses, Constantine's group determined response thresholds in responders to treatment by a lowered frequency of 36 or more moderate-to-severe vasomotor symptoms per week after 4 weeks of treatment. A response threshold of a reduction in frequency of 39 or more moderate-to-severe vasomotor symptoms per week was determined after 12 weeks of treatment.

"Clinically meaningful improvements were observed despite the high placebo response rate in this study," Constantine noted, adding that "TX-001HR, which is in development, if approved, may provide a new oral option, as a single 17β-estradiol/progesterone capsule, to treat moderate-to-severe vasomotor symptoms in menopausal women with an intact uterus, including those women who are currently seeking unapproved compounded hormones."

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