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Continuous, Combined Hormone Replacement: Randomized Comparison of Transdermal and Oral Preparations

From the Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Göteborg, Sweden; and the Department of Pathology, University of Basle and Novartis Pharma AG, Basle, Switzerland.

Address reprint requests to: Lars A. Mattsson, MD, PhD, Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, East, S-416 85 Göteborg, Sweden

Objective: To compare two new transdermal, continuous, combined formulations and an oral regimen of hormone replacement therapy (HRT) with respect to endometrial hyperplasia, bleeding patterns, and climacteric symptoms in postmenopausal women.

Methods: This was a randomized, open, parallel-group trial during 1 year in 441 postmenopausal women who received either a 10-cm² patch of 0.025 mg estradiol (E2) and 0.125 mg norethisterone acetate, a 20-cm² patch of 0.05 mg E2 and 0.25 mg norethisterone acetate twice weekly, or tablets of 2 mg E2 and 1 mg norethisterone acetate once daily. The efficacy variables were frequency of endometrial hyperplasia after 1 year of treatment, number of bleeding and spotting days from the fourth to sixth treatment months, relief of climacteric symptoms, and tolerability.

Results: The frequency of endometrial hyperplasia was no more than 2% after 1 year of treatment in all groups. One case of simple hyperplasia was detected among the women treated with 10-cm² patches and two among those treated with oral HRT. From the fourth to sixth treatment months, amenorrhea occurred in 73%, 47%, and 66% of the women in the 10-cm², 20-cm², and oral HRT groups, respectively. The 10-cm² patches and oral treatment were associated with fewer bleeding days than were the 20-cm² patches (P < .001). During the last 3 months of the treatment year, amenorrhea was found in 100 subjects (86%) for 10-cm² patches, 61 (65%) for 20-cm² patches, and in 85 (79%) for oral HRT. All treatments alleviated the climacteric symptoms to a comparable extent.

Conclusion: In postmenopausal women, 10-cm² patches relieved climacteric symptoms and prevented endometrial hyperplasia at least as effectively as oral HRT. Amenorrhea was induced early in a high percentage of women using 10-cm² patches and oral HRT, and these therapies seemed to be convenient, effective, and safe for estrogen deficiency symptoms in postmenopausal women.

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