Effects of estetrol/drospirenone on Self-Reported Physical and Emotional Premenstrual and Menstrual Symptoms: Data from the Phase 3 Clinical Trial in the United States and Canada.

Abstract

Objective: To describe the effects of estetrol 15mg/drospirenone 3mg on physical and emotional premenstrual and menstrual symptoms in a North American population.

Study design: We used Menstrual Distress Questionnaire (MDQ) data from an open-label phase 3 trial conducted in the United States and Canada that enrolled participants 16-50 years to use estetrol/drospirenone for up to 13 cycles. Four most bothersome MDQ domains were evaluated: the physical domains of Pain and Water Retention and the emotional domains of Negative Affect and Impaired concentration. We assessed mean changes from baseline to end of treatment in premenstrual and menstrual scores in starters and switchers (use of hormonal contraception in prior 3 months) and performed a shift analysis on individual symptoms within each domain.

Results: Of 1,864 treated participants, 1,308 (70.2%) completed both MDQs of which 676 (51.7%) were starters and 1179 (90.1%) were US participants. Starters reported significant improvements (p<0.05) for menstrual Pain (-3.3), premenstrual (-1.5) and menstrual (-2.0) Water Retention and premenstrual Negative Affect (-1.2). Switchers reported no significant changes in any of the four domains. We observed a decrease in symptom intensity in >40% of participants within the domain Pain for Headache, Cramps, Backache, Fatigue, and General Aches and Pain; within the domain Water Retention for Weight Gain, Skin Blemish, Painful or Tender Breast, and Swelling; and within the domain Negative Affect for Anxiety, Mood Swings, and Irritability.

Conclusion: Estetrol/drospirenone starters experienced the most significant improvements in the MDQ domains Pain, Water Retention, and Negative Affect. Domain scores for switchers remained stable.