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Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions (continued)
Appendix Table. Randomized, Controlled Trials Included in This Update
| Trial (Reference) | Intervention | Participants | Outcomes |
|---|---|---|---|
| WHI estrogen plus progestin trials | |||
| Main trial (3, 14, 17, 20, 22, 23, 25, 27, 29, 30, 32, 35, 36, 38, 39, 40) | CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo (8506 vs. 8102 participants) for 5.2 y | Postmenopausal women without hysterectomies, aged 50–79 y, recruited across the United States | Invasive breast, colorectal, lung, or endometrial cancer; all-cause mortality; fractures; thromboembolic events (deep venous thrombosis or pulmonary embolism); coronary heart disease events; stroke; diabetes; gallbladder disease; cognitive function; and urinary incontinence |
| Postintervention phase (21, 28, 26) | CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo for 8.6 years of cumulative use | 95% of women from the main trial who provided follow-up information | Invasive breast, colorectal, lung, or endometrial cancer; all-cause mortality; fractures; thromboembolic events; coronary heart disease events; and stroke |
| Extension phase (18) | CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo for 11 y of cumulative use | 83% of women from the main trial who consented for the extension phase | Invasive breast cancer |
| WHIMS (41, 43, 45) | CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo (2229 vs. 2303 participants) for 4.1 y | WHI trial participants aged >65 y and free of probable dementia | Cognitive function |
| WHISCA (46, 48) | CEE, 0.625 mg/d, plus MPA, 2.5 mg/d, vs. placebo (690 vs. 726 participants) for 1.4 y | WHIMS trial participants at 1 of 14 WHIMS centers | Cognitive function |
| WHI estrogen-only trials | |||
| Main trial (2, 15, 16, 19, 23, 24, 30, 31, 33, 37, 38) | CEE, 0.625 mg/d, vs. placebo (5310 vs. 5429 participants) for 6.8 y | Postmenopausal women with hysterectomies, aged 50–79 y, recruited across the United States | Invasive breast, colorectal, or lung cancer; all-cause mortality; fractures; thromboembolic events; coronary heart disease events; stroke; diabetes; gallbladder disease; cognitive function; and urinary incontinence |
| Extension phase (18, 34, 63) | CEE, 0.625 mg/d, vs. placebo for 10.7 y of cumulative use | 78% of women from the main trial who consented for the extension phase | Invasive breast cancer or colorectal cancer, all-cause mortality, fractures, thromboembolic events, coronary heart disease events, and stroke |
| WHIMS (42, 44) | CEE, 0.625 mg/d, vs. placebo (1464 vs. 1483 participants) for 4.1 years | WHI trial participants aged >65 y and free of probable dementia | Cognitive function |
| WHISCA (46, 47) | CEE, 0.625 mg/d, vs. placebo (434 vs. 452 participants) for 1.4 years | WHIMS trial participants at 1 of 14 WHIMS centers | Cognitive function |
| HERS | |||
| Main trial (50, 54–56) | CEE, 0.625 mg/d, plus MPA, 2.5 mg, vs. placebo (1380 vs. 1383 participants) for 4.1 years | Postmenopausal women with established coronary artery disease but no hysterectomies, aged ≤ 80 y, recruited across the United States | Invasive breast, colorectal, lung, or endometrial cancer; all-cause mortality; fractures; diabetes; cognitive function; and urinary incontinence |
| Follow-up (HERSII) (52, 53) | CEE, 0.625 mg/d, plus MPA, 2.5 mg, vs. placebo (1156 vs. 1165 participants) for 6.8 years cumulative use | 93% of women from the HERS trial who consented for follow-up | Invasive breast, colorectal, lung, or endometrial cancer and all-cause mortality |
| ESPRIT (57) | Estradiol valerate, 2 mg/d, vs. placebo (513 vs. 504 participants) for 2 y | Women aged 50–60 y admitted to coronary care units or general medical wards, met diagnostic criteria for initial myocardial infarction, and were discharged from the hospital within 31 d of admission | Invasive breast cancer |
| EMS (49) | 17-ß estradiol, 1 mg/d, for 4 days then 17-β estradiol, 1 mg, plus norethindrone, 0.35 mg/d, for 3 days, repeated every week vs. placebo (70 vs. 72 participants) for 2 y | Postmenopausal women both with and without hysterectomies, age >60 y | Invasive breast cancer and cognitive function |
| ULTRA (58–61) | Transdermal estradiol, 0.014 mg/d, vs. placebo (208 vs. 209 participants) for 2 y | Postmenopausal women without hysterectomies who had normal bone mineral density | Fractures, cognitive function, and urinary incontinence |
| WISDOM (62) | CEE, 0.625 mg/d, plus MPA, 2.5–5.0 mg/d, vs. placebo (2196 vs. 2189 participants) for 11.9 mo | Postmenopausal women age 50–69 y | Invasive breast cancer |
CEE = conjugated equine estrogen; EMS = Estrogen Memory Study; ESPRIT = Oestrogen in the Prevention of Reinfarction Trial; HERS = Heart and Estrogen/progestin Replacement Study; MPA = medroxyprogesterone acetate; ULTRA = Ultra–Low-Dose Transdermal Estrogen Assessment; WHI = Women’s Health Initiative; WHIMS = Women’s Health Initiative Memory Study; WHISCA = Women’s Health Initiative Study of Cognitive Aging; WISDOM = Women's International Study of Long-Duration Oestrogen After Menopause.
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