Relief of vasomotor symptoms and vaginal atrophy with lower doses of conjugated equine estrogens and medroxyprogesterone acetate

Utian, Wulf H; Shoupe, Donna; Bachmann, Gloria; Pinkerton, Joanne V; Pickar, James H

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Volume 75, Issue 6 , Pages 1065-1079, June 2001

Relief of vasomotor symptoms and vaginal atrophy with lower doses of conjugated equine estrogens and medroxyprogesterone acetate☆

Wulf H Utian, M.D., Ph.D.
- Case Western Reserve University, Cleveland, Ohio, USA
- Department of Obstetrics and Gynecology, Case Western Reserve University.
- Reprint requests: Wulf H. Utian, M.D., Ph.D., Executive Director, The North American Menopause Society, 5900 Landerbrook Drive, Suite 195, Mayfield Heights, Ohio 44124. (FAX: 440-442-2660)
Donna Shoupe, M.D.
- Keck School of Medicine, University of Southern California, Los Angeles, California, USA
- Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California.
Gloria Bachmann, M.D.
- University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA
- Department of Obstetrics and Gynecology, UMDNJ–Robert Wood Johnson Medical School.
Joanne V Pinkerton, M.D.
- University of Virginia Health Sciences Center, Charlottesville, Virginia, USA
- Department of Obstetrics and Gynecology, University of Virginia Health Sciences Center.
James H Pickar, M.D.
- Wyeth-Ayerst Research, Philadelphia, Pennsylvania, USA
- Wyeth-Ayerst Research.

Received 14 November 2000; received in revised form 16 January 2001; accepted 16 January 2001.

Abstract

Objective: To evaluate the efficacy of lower doses of conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA) for relieving vasomotor symptoms and vaginal atrophy.

Design: A randomized, double-blind, placebo-controlled trial (the Women’s Health, Osteoporosis, Progestin, Estrogen study).

Setting: Study centers across the United States.

Patient(s): Two thousand, six hundred, seventy-three healthy, postmenopausal women with an intact uterus, including an efficacy-evaluable population (n = 241 at baseline).

Intervention(s): Patients received for 1 year (13 cycles; in milligrams per day) CEE, 0.625; CEE, 0.625 and MPA, 2.5; CEE, 0.45; CEE, 0.45 and MPA, 2.5; CEE, 0.45 and MPA, 1.5; CEE, 0.3; CEE, 0.3 and MPA, 1.5; or placebo.

Main Outcome Measure(s): Number and severity of hot flushes and Papanicolaou smear with vaginal maturation index (VMI) to assess vaginal atrophy.

Result(s): In the efficacy-evaluable population, reduction in vasomotor symptoms was similar with CEE of 0.625 mg/d and MPA of 2.5 mg/d (the most commonly prescribed doses) and all lower combination doses. CEE of 0.625 mg/d alleviated hot flushes more effectively than the lower doses of CEE alone. VMI improved in all active treatment groups.

Conclusion(s): Lower doses of CEE plus MPA relieve vasomotor symptoms and vaginal atrophy as effectively as commonly prescribed doses.

Keywords: Conjugated equine estrogens (CEE), medroxyprogesterone acetate (MPA), lower doses, vasomotor symptoms, Women’s HOPE study, hormone replacement therapy (HRT), vaginal maturation index (VMI), vaginal atrophy, postmenopausal women, menopause