PEPI
Effects of hormone replacement therapy on endometrial histology in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial
N = 596
- Population
- Postmenopausal women aged 45 through 64 years without contraindication to hormone therapy
- Design
- Three-year multicentre, randomised, double-masked, placebo-controlled trial. 596 postmenopausal women aged 45 through 64 years without contraindication to hormone therapy were randomised, in 28-day cycles, to placebo, conjugated equine estrogens (CEE) alone, or CEE plus one of three progestin regimens. The outcome measure was endometrial histology from biopsy, curettage or hysterectomy at baseline, annual or unscheduled visits; analysis by intention to treat.
- Arms
- Placebo (control): Placebo
- CEE alone (experimental): 0.625 mg/d conjugated equine estrogens (CEE)
- CEE plus MPA for 12 days (experimental): 0.625 mg/d CEE plus 10 mg/d medroxyprogesterone acetate (MPA) for the first 12 days
- CEE plus MPA 2.5 mg/d (experimental): 0.625 mg/d CEE plus 2.5 mg/d MPA
- CEE plus micronized progesterone (experimental): 0.625 mg/d CEE plus 200 mg/d micronized progesterone for the first 12 days
- People
- Writing Group for the PEPI Trial, Writing Group for the PEPI Trial
Δ Simple (cystic) hyperplasia+26.9 pointsΔ Complex (adenomatous) hyperplasia+21.9 pointsΔ Atypical hyperplasia+11.8 points
Show the numbers
| Endpoint | Analysis | CEE alone / CEE plus MPA for 12 days / CEE plus MPA 2.5 mg/d / CEE plus micronized progesterone | Placebo | Effect |
|---|---|---|---|---|
| Simple (cystic) hyperplasia | primaryWriting 1996 | 27.7% | 0.8% | P<.001CEE alone vs placebo. The abstract states that participants given any of the three estrogen-plus-progestin regimens had hyperplasia rates similar to placebo (P = .16); per-regimen percentages are not given in the abstract. |
| Complex (adenomatous) hyperplasia | primaryWriting 1996 | 22.7% | 0.8% | P<.001CEE alone vs placebo. |
| Atypical hyperplasia | primaryWriting 1996 | 11.8% | 0% | P<.001CEE alone vs placebo. One woman developed endometrial adenocarcinoma while receiving placebo (abstract). |
| Endpoint | Analysis | CEE alone / CEE plus MPA for 12 days / CEE plus MPA 2.5 mg/d / CEE plus micronized progesterone | Placebo | Effect |
|---|---|---|---|---|
| Simple (cystic) hyperplasia | primaryWriting 1996 | 27.7% | 0.8% | P<.001CEE alone vs placebo. The abstract states that participants given any of the three estrogen-plus-progestin regimens had hyperplasia rates similar to placebo (P = .16); per-regimen percentages are not given in the abstract. |
| Complex (adenomatous) hyperplasia | primaryWriting 1996 | 22.7% | 0.8% | P<.001CEE alone vs placebo. |
| Atypical hyperplasia | primaryWriting 1996 | 11.8% | 0% | P<.001CEE alone vs placebo. One woman developed endometrial adenocarcinoma while receiving placebo (abstract). |