Randomised trial, 2024
Does estetrol/drospirenone birth control improve PMS symptoms?
Yes. Women who started this birth control experienced significant improvements in pain, bloating, and negative mood symptoms. Women already on other birth control saw minimal improvements.
What they did
Phase 3 randomized trial with 1,553 women in Europe and Russia who took estetrol 15mg/drospirenone 3mg birth control for up to 13 cycles. Participants rated PMS-related symptoms at the start and end of treatment using the Menstrual Distress Questionnaire.
What they found
New birth control users reported premenstrual pain improvement of -1.4 points, bloating improvement of -3.3 points, and negative mood improvement of -2.5 points. Menstrual pain improved -3.5 points, bloating -3.4 points, and negative mood -2.7 points. More than 40% experienced changes in cramping, backache, fatigue, breast tenderness, swelling, mood swings, and irritability. Women switching from other birth control reported minimal changes.
What it means for you
This birth control helps reduce PMS symptoms for new users, especially those with worse baseline symptoms. Women already using other birth control saw less benefit.
1,553
women in trial
531
new users
13
cycles
About the study
- Original title
- Effects of E4/DRSP on self-reported physical and emotional premenstrual and menstrual symptoms: data from the phase 3 clinical trial in Europe and Russia
- Authors
- Bitzer J, Bouchard C, Zatik J et al.
- Journal
- The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception
- Year
- 2024
- Study design
- Randomised trial
- Participants
- 1,553
- What was tested
- Estetrol 15mg/drospirenone 3mg birth control taken for up to 13 cycles
- Open access
- Yes
- Read the paper
- doi.org/10.1080/13625187.2024.2359117
Original abstract
Purpose: To describe the effects of estetrol (E4) 15 mg / drospirenone (DRSP) 3 mg on physical and emotional premenstrual and menstrual symptoms. Materials and methods: We used Menstrual Distress Questionnaire (MDQ) data from a phase-3 trial (NCT02817828) in Europe and Russia with participants (18 - 50 years) using E4/DRSP for up to 13 cycles. We assessed mean changes in MDQ- t -scores from baseline to end of treatment in premenstrual (4 days before most recent flow) and menstrual (most recent flow) scores for 4 MDQ domains 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 1,553 treated participants, 1,398(90.0%), including 531(38%) starters, completed both MDQs. Starters reported improvements for premenstrual Pain (-1.4), Water Retention (-3.3) and Negative Affect (-2.5); and for menstrual Pain (-3.5), Water Retention (-3.4), and Negative Affect (-2.7) (all p p = 0.02) and menstrual (+1.5, p = 0.003) Water Retention. We observed a change in symptom intensity in >40% of participants for Cramps, Backache and Fatigue (domain Pain), Painful or Tender Breast and Swelling (domain Water Retention) and Mood Swings and Irritability (domain Negative Affect). Conclusion: E4/DRSP starters experienced significant improvements in the domains Pain, Water Retention and Negative Affect particularly benefiting those with more severe baseline symptoms. Switchers showed minimal changes.
Reproduced under CC-BY.
Topics
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