Changes in the withdrawal bleeding pattern and endometrial histology during 17 beta-estradiol-dydrogesterone therapy in postmenopausal women: a 2 year prospective study.

OBJECTIVE

To describe changes in the withdrawal bleeding pattern and endometrial histology during a sequential 17 beta-estradiol-dydrogesterone regimen in postmenopausal women.

DESIGN

Open-label, non-comparative, prospective study.

SETTING

Gynecological outpatient department of a university hospital.

PATIENTS

Twenty-seven healthy non-hysterectomized postmenopausal women.

INTERVENTIONS

Continuous micronized 17 beta-estradiol supplementation, 2 mg daily, and cyclic administration of dydrogesterone, 10 mg daily for the first half of each 28 day treatment cycle.

MAIN OUTCOME MEASURES

Changes in the characteristics of the withdrawal bleeding pattern and the endometrial biopsy histology during 2 years of treatment.

RESULTS

The initial withdrawal bleeding was comparable to normal menstruation with respect to amount and duration. During the 2 years of treatment the bleeding showed a significant tendency to become shorter with less blood loss. This was mainly the result of the decrease (P < 0.001) in the number of days per cycle with bleeding grade II (normal menstruation). None of the women developed endometrial hyperplasia, and in almost all women the given hormone replacement therapy regimen induced secretory or atrophic changes of the endometrium.

CONCLUSIONS

This sequential 17 beta-estradiol-dydrogesterone regimen can be regarded as safe with respect to the prevention of endometrial disease and appeared to foster patient compliance.