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Endometrial safety and bleeding pattern during a five-year treatment with long-cycle hormone therapy

Ödmark, Inga-Stina MD, PhD1; Bixo, Marie MD, PhD1; Englund, Doris MD, PhD2; Risberg, Björn MD, PhD3; Jonsson, Björn PhD4; Olsson, Sven-Eric MD, PhD5

doi: 10.1097/01.gme.0000185119.74706.7b
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Objective: To determine compliance, the incidence of untoward effects, and endometrial safety in postmenopausal women treated with 3-month sequential hormone therapy for up to 5 years.

Design: A prospective, uncontrolled multicenter study of 129 women treated with 0.625 mg conjugated estrogens daily plus 10 mg medroxyprogesterone acetate for 14 days every third month. Endometrial biopsy samples were taken before the initiation of the study and then yearly during the next 5 years. Bleeding patterns were recorded.

Results: Upon completion of the first 12 months of treatment, 76 of 126 biopsied women (60%) had secretory endometrium. After 5 years, this finding was reversed in biopsy specimens completed by 59 women, among whom 32 (56%) had insufficient or atrophic endometrium. We did not find any hyperplasia when the biopsy specimen was taken according to the protocol. One endometrial cancer was found by biopsy after 12 months, but the subsequent hysterectomy showed no sign of cancer. Ultrasound determinations of mean endometrial thickness during therapy showed a thin endometrium (mean = 4 mm, range = 1-13 mm). Amenorrhea was reported by 6.2% of 129 women after 12 months of treatment. Among the 59 women who completed the study, 71.2% had regular bleeding patterns every third month, 25.4% reported amenorrhea, and 3.4% had irregular bleeding patterns.

Conclusions: The addition of 10 mg of medroxyprogesterone acetate for 14 days every third month to treatment with 0.625 mg of conjugated estrogens daily was well tolerated, and was associated with high endometrial safety.

Treatment for climacteric symptoms with 0.625 mg of conjugated estrogens daily and 10 mg of medroxyprogesterone acetate for 14 days every third month during a 5-year period was well tolerated, and was associated with high endometrial safety.

From the 1Department of Clinical Science, Obstetrics and Gynecology, University of Umeå, Umeå, Sweden; 2The Obstetrics and Gynecologic Center, Uppsala, Sweden; 3Department of Pathology, The Norwegian Radium Hospital, Oslo, Norway; 4Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden; and 5Department of Obstetrics and Gynecology, Karolinska Institute at Danderyds hospital, Stockholm, Sweden.

Received November 8, 2004, revised and accepted February 14, 2005.

This study was performed through Wyeth Lederle Nordiska AB. The supply for the study was supported from Wyeth-Ayerst Pharmaceutical during the first year. The study was performed by the following investigators: Doris Englund, Uppsala, Susanne Damm, Linköping, Agneta Schnittger, Linköping, Erik Hemmingsson, Östersund, Margareta Linden, Stockholm, Ulf Ljungblad, Borås, Torkild Nielsen, Borås, Staffan Nilsson, Falun, Bente Simonsen, Falun and pathologist Vera Abeler, Oslo.

Address correspondence to: Marie Bixo, Department of Clinical Sciences, Obstetrics and Gynecology, Umeå University, S-901 85 Umeå, Sweden. E-mail: marie.bixo@obgyn.umu.se.

©2005The North American Menopause Society