Oestradiol–progesterone pill effective in moderate-to-severe vasomotor symptoms
TX-001HR, a fixed-dose combination of oestradiol and progesterone, yields clinically meaningful improvements in the frequency and/or severity vasomotor symptoms (VMS) in menopausal women with a uterus, according to a study.
With the aim of determining what reduction in VMS frequency was meaningful to women, researchers drew data from the REPLENISH trial and enrolled 726 women (mean age 55 years; mean body mass index, 27 kg/m2) in a VMS substudy. Participants were randomized to receive TX-001HR (17β-estradiol/progesterone) at a dose of 1 mg/100 mg (n=141), 0.5 mg/100 mg (n=149), 0.5 mg/50 mg (n=147) or 0.25 mg/50 mg (n=154) or placebo (n=135) daily.
The Clinical Global Impression and the Menopause-Specific Quality of Life (MENQOL) questionnaire facilitated definition of clinical responders, clinically important differences (CIDs) or minimal CID (MCID) in VMS frequency. Response thresholds were determined by nonparametric discriminant analyses utilizing bootstrapping methods.
Significantly more women in the TX-001HR vs placebo group achieved a Clinical Global Impression–based clinical response for MCID (weekly reduction of ≥25 moderate–severe VMS: 82–88 percent vs 69 percent; p<0.05 for all) and CID (weekly reduction of ≥39 VMS: 68–73 percent vs 52 percent; p<0.05 for all) at week 12. Week 4 results were similar.
For Menopause Quality of Life–based analysis, TX-001HR yielded a significantly higher response than placebo for MCID (weekly reduction of ≥34 VMS: 74–81 percent vs 55 percent; p<0.01 for all) and CID (weekly reduction of ≥44 VMS: 61–69 percent vs 42 percent; p<0.01 for all) at week 12.
The results of the present analysis extend the primary efficacy results of the REPLENISH trial, which showed significant improvements in the frequency and severity of moderate-to-severe VMS with TX-001HR vs placebo at weeks 4 and 12, researchers said. [Obstet Gynecol 2018;132:161-170]
If approved, TX-001HR may provide a new option for treating VMS in menopausal women with an intact uterus using oestrogen and progesterone, similar to the hormones naturally occurring in women, in a single, oral capsule, they added.