ID-5184 Wonca Abstracts supplement A-K 13-10-23 - Flipbook - Page 70
WONCA 2023 Supplement 1: WONCA 2023 abstracts (A–K)
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Effects of E4/DRSP on self-reported premenstrual and
menstrual mood symptoms: Pooled data from two Phase 3
clinical trials
Prof Deborah Bateson1, Céline Bouchard2, Johannes Bitzer3, Mitchell D Creinin4, Jean-Michel Foidart5
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Faculty of Medicine and Health, University of Sydney, 2Clinique de Recherche en Santé des Femmes,
Quebec, 3Department of Obstetrics and Gynecology, University Hospital of Basel, 4Department of
Obstetrics and Gynecology, University of California, Davis, 5Department of Gynecology and Obstetrics,
University of Liège, Liège
Background
Positive and negative mood changes can occur with hormonal contraceptive use.
Objective
This study assessed self-reported mood during two Phase 3 studies of a new oral contraceptive with
oestetrol (E4) 15 mg/drospirenone (DRSP) 3 mg (24-day hormone/4-day placebo regimen).
Methods
Healthy starters (no hormonal contraception in prior three months) and switchers (16−50 years) used
E4/DRSP for up to 13 cycles. Participants completed a Menstrual Distress Questionnaire (MDQ), a
validated inventory that helps clinicians to assess premenstrual and menstrual symptoms, at baseline
and at the end of the trial. Data were pooled from the two trials to evaluate changes in t-scores for
the domain ‘Negative Affect’ (possible range 31−103) and compared using Student’s t-test with P
< 0.05 considered statistically significant. The proportions of participants reporting no change, an
improvement or a worsening (intensity categories: none/mild/moderate/severe) for the symptoms
‘Feeling Sad/Blue’ and ‘Mood Swings’ within the ‘Negative Affect’ domain were also calculated.
Results
Of 3417 treated participants, 2707 (79.2%) completed baseline and end-of-trial MDQs; 1207 (44.6%)
were starters. Mean baseline t-scores were in the lower range (45−50). Starters reported significant
improvement of premenstrual (–1.77; P < 0.0001) and menstrual (–1.72; P < 0.0001) ‘Negative Affect’
domain scores. At the end of the trial, the proportions of starters reporting no change in premenstrual/
menstrual ‘Feeling Sad/Blue’ were 64.9%/65.0%, with 20.6%/19.8% reporting improvement and
14.4%/15.2% worsening. The proportions reporting no change in premenstrual/menstrual ‘Mood
Swings’ were 47.0%/47.3%, with 31.6%/31.2% reporting improvement and 21.5%/21.6% worsening.
Overall, baseline and end-of-trial evaluations showed more starters reporting not ‘Feeling Sad/Blue’
(premenstrual 67.9% and 73.1%, respectively; menstrual 68.5% and 76.6%, respectively) and not
having ‘Mood Swings’ (premenstrual 44.0% and 51.1%, respectively; menstrual 43.0% to 52.2%,
respectively). Among switchers, only small changes were found in any assessed outcomes.
Conclusion
Most E4/DRSP users who had not recently used hormonal contraception reported an improvement or
no change in negative affect symptoms. Switchers reported minimal changes.
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