Figures & data
Figure 1. Mean steady-state serum (a) progesterone (P4) and (b) estradiol (E2) concentrations following daily oral administration of 1 mg E2/100 mg P4 (no baseline adjustment) at day 7.
![Figure 1. Mean steady-state serum (a) progesterone (P4) and (b) estradiol (E2) concentrations following daily oral administration of 1 mg E2/100 mg P4 (no baseline adjustment) at day 7.](/cms/asset/8123bc4a-b1fa-4240-8bbe-1e042ddf8eec/ierj_a_1637731_f0001_b.gif)
Table 1. Main inclusion and exclusion criteria in the REPLENISH study.
Table 2. Participant demographics and baseline characteristics of the modified intent-to-treat (MITT)-VMS population.
Figure 3. Weekly reduction in VMS (a) frequency and (b) severity in MITT-VMS population. For (a) p < 0.05 versus placebo from *weeks 3–12; †weeks 4–12; ‡weeks 6–12; for (b) p < 0.05 versus placebo from *weeks 3–12; †weeks 7, 9–12; ‡weeks 6, 7, 9. Weekly severity score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3]/(total number of mild, moderate and severe hot flushes over 7 days). E2: 17β-estradiol; MITT: modified intent-to-treat; P4: progesterone; VMS: vasomotor symptoms. Reprinted with permission from Lobo et al [Citation30].
![Figure 3. Weekly reduction in VMS (a) frequency and (b) severity in MITT-VMS population. For (a) p < 0.05 versus placebo from *weeks 3–12; †weeks 4–12; ‡weeks 6–12; for (b) p < 0.05 versus placebo from *weeks 3–12; †weeks 7, 9–12; ‡weeks 6, 7, 9. Weekly severity score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3]/(total number of mild, moderate and severe hot flushes over 7 days). E2: 17β-estradiol; MITT: modified intent-to-treat; P4: progesterone; VMS: vasomotor symptoms. Reprinted with permission from Lobo et al [Citation30].](/cms/asset/ebd68eba-5c26-48b8-ab84-cdaea1876dc1/ierj_a_1637731_f0003_oc.jpg)
Figure 4. Mean reduction from baseline in Menopause-specific Quality of Life (MENQOL) (a) overall and (b) vasomotor domain scores in MITT-VMS population and in Medical Outcome Study (MOS)-Sleep (c) total and (d) Sleep Problems Index I scores in MITT population. *p < 0.05; †p < 0.01; ‡p < 0.001 vs placebo. Sleep Problems Index I based on the following questions: How often during the past 4 weeks did you: Get enough sleep to feel rested upon waking; Awaken short of breath or with a headache; Have trouble falling asleep; Awaken and have trouble falling asleep again; Have trouble staying awake during the day; Get the amount of sleep you needed? E2, 17β-estradiol; MITT, modified intent-to-treat; P4, progesterone; VMS: vasomotor symptoms. Figure 4(a,b) adapted with permission from Simon et al [Citation36] Figure 4(c,d) adapted with permission from Kagan et al [Citation37].
![Figure 4. Mean reduction from baseline in Menopause-specific Quality of Life (MENQOL) (a) overall and (b) vasomotor domain scores in MITT-VMS population and in Medical Outcome Study (MOS)-Sleep (c) total and (d) Sleep Problems Index I scores in MITT population. *p < 0.05; †p < 0.01; ‡p < 0.001 vs placebo. Sleep Problems Index I based on the following questions: How often during the past 4 weeks did you: Get enough sleep to feel rested upon waking; Awaken short of breath or with a headache; Have trouble falling asleep; Awaken and have trouble falling asleep again; Have trouble staying awake during the day; Get the amount of sleep you needed? E2, 17β-estradiol; MITT, modified intent-to-treat; P4, progesterone; VMS: vasomotor symptoms. Figure 4(a,b) adapted with permission from Simon et al [Citation36] Figure 4(c,d) adapted with permission from Kagan et al [Citation37].](/cms/asset/bcc83a26-7cc5-42a7-84a7-24146c504b44/ierj_a_1637731_f0004_oc.jpg)
Table 3. Treatment-related TEAEs occurring in ≥3% in any treatment arm and more commonly than placebo and treatment-related serious AEs (safety population).
Figure 5. Cumulative (a) amenorrhea and (b) no bleeding in safety population. *p < 0.05; †p ≤ 0.01; ‡p < 0.001 vs placebo. Cycles are 28 days in length. E2, 17β-estradiol; P4, progesterone.
![Figure 5. Cumulative (a) amenorrhea and (b) no bleeding in safety population. *p < 0.05; †p ≤ 0.01; ‡p < 0.001 vs placebo. Cycles are 28 days in length. E2, 17β-estradiol; P4, progesterone.](/cms/asset/03140bdf-f3aa-4773-8421-d32b31cab92a/ierj_a_1637731_f0005_oc.jpg)