Menopausal symptom control and side-effects on continuous estrone sulfate and three doses of medroxyprogesterone acetate. Ogen/Provera Study Group.

OBJECTIVES

To establish the optimum oral daily dose of micronized medroxyprogesterone acetate (MPA), given in combination with 1.25 mg of estrone sulfate for menopausal symptom control.

METHODS

This multicenter, randomized, double-blind study was conducted on 568 postmenopausal women who were randomized to take estrone sulfate 1.25 mg daily with 2.5, 5.0 or 10 mg of MPA daily for 2 years. The number of vasomotor symptoms and the severity of mood swings, lethargy, vaginal dryness and loss of libido as well as side-effects were recorded in a diary. Blood pressure and weight were recorded at each 3-month visit.

RESULTS

Vasomotor symptoms were reported by approximately 80% of subjects at month 1, 23% at month 3 but only 9% by month 24. Mood swings, lethargy and vaginal dryness improved rapidly in the initial 3 months of therapy. Decrease in libido had a slower response to therapy in all three treatment groups. Breast tenderness was the commonest side-effect with 22% of subjects complaining of this in the first 3 months of therapy, dropping to 13% by 6 months. Headache, depression, nausea, bloating and irritability showed a similar pattern of decline. There was no significant difference in the rate of decrease in menopausal symptoms or reported side-effects between the three treatment groups. There was a small but significant (p < 0.001) decrease in systolic and diastolic blood pressure over the study period.

CONCLUSIONS

All three treatment regimens provide adequate symptom control. Side-effects decreased markedly after the first 3 months, with no significant difference between the treatment groups.