Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone

• Published in: American journal of obstetrics and gynecology Vol. 170; no. 5; pp. 1213 - 1223
• Main Authors: Woodruff, J. Donald, Pickar, James H.
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Elsevier Inc 01.05.1994; Elsevier
• Subjects: Biological and medical sciences; conjugated estrogens; endometrial hyperplasia; Estrogen replacement therapy; Genital system. Reproduction; hormone replacement therapy; Medical sciences; medroxyprogesterone acetate; menopause; Pharmacology. Drug treatments; Premarin; progestin; progestin; Estrogen replacement therapy; menopause; endometrial hyperplasia; medroxyprogesterone acetate; hormone replacement therapy; Premarin; conjugated estrogens; Human; Drug combination; Replacement therapy; Hyperplasia; Estrogen; Oral administration; Prevention; Chemotherapy; Medroxyprogesterone; Postmenopause; Progesterone; Sex steroid hormone; Endometrium
• ISSN: 0002-9378; 1097-6868
• DOI: 10.1016/S0002-9378(13)90437-3

OBJECTIVE: We evaluated four oral combinations of conjugated estrogens (Premarin) and medroxyprogesterone acetate in preventing endometrial hyperplasia, which can occur with conjugated estrogens alone. STUDY DESIGN: This was a 1-year prospective, double-blind, randomized, multicenter study in 1724 postmenopausal women. All five groups took conjugated estrogens (0.625 mg) daily. The respective medroxyprogesterone acetate dosages were 2.5 and 5.0 mg daily (groups A and B) and 5.0 and 10.0 mg for 14 days per 28-day cycle (groups C and D). RESULTS: Among the 1385 patients with valid biopsy data, endometrial hyperplasia developed in 20% in the conjugated estrogens treated group and ≤ 1 % in each of the four conjugated estrogens/medroxyprogesterone acetate-treated groups. The incidence of endometrial hyperplasia did not differ significantly between any of the conjugated estrogens/medroxyprogesterone acetate regimens. However, none of the patients receiving the two higher medroxyprogesterone acetate dosages (groups B and D)r had endometrial hyperplasia. CONCLUSION: The endometrial hyperplasia incidence was significantly lower in women treated with conjugated estrogens and medroxyprogesterone acetate than in women treated with conjugated estrogens alone.