Non-randomised trial, 2025
Does the pill estetrol/drospirenone ease period pain, bloating and premenstrual mood symptoms?
For women trying this pill for the first time, yes, it significantly eased pain, water retention and negative mood. For women switching from another pill, symptoms stayed about the same rather than improving.
What they did
An open-label phase 3 trial in the US and Canada gave estetrol 15 mg/drospirenone 3 mg for up to 13 cycles to participants aged 16-50. A symptom questionnaire tracked four areas before and after treatment: Pain, Water Retention, Negative Affect, and Impaired Concentration, comparing women new to hormonal contraception (starters) with those switching from another method (switchers).
What they found
Of 1,864 women treated, 1,308 (70.2%) completed questionnaires at both time points; 676 (51.7%) were starters and 1,179 (90.1%) were from the US. Starters showed significant improvements in Pain, Water Retention and Negative Affect scores. Over 40% of starters improved on symptoms like headache, cramps, backache, fatigue, weight gain, breast tenderness, swelling, anxiety, mood swings and irritability. Switchers' scores stayed stable.
What it means for you
This pill may meaningfully reduce period pain, bloating-type symptoms and premenstrual mood issues for first-time hormonal contraceptive users. Switchers may not see extra benefit. There was no placebo group and no blinding, so some improvement in starters could partly reflect expectation rather than the pill alone.
70.2%
Completed questionnaires at both time points
51.7%
Were first-time users (starters)
>40%
Improved on individual symptoms
About the study
- Original title
- 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
- Authors
- Bouchard C, Bitzer J, Chen MJ et al.
- Journal
- Contraception
- Year
- 2025
- Study design
- Non-randomised trial
- Participants
- 3
- What was tested
- Estetrol 15 mg / drospirenone 3 mg contraceptive pill, taken for up to 13 cycles
- Open access
- Yes
- Read the paper
- doi.org/10.1016/j.contraception.2025.110889
Original abstract
Objective: To describe the effects of estetrol 15mg/drospirenone 3 mg 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 1864 treated participants, 1308 (70.2%) completed both MDQs of which 676 (51.7%) were starters and 1179 (90.1%) were US participants. Starters reported significant improvements (p 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. Implications: In first time pill users, the estetrol/drospirenone containing oral contraceptive significantly reduces menstrual pain, premenstrual and menstrual water retention and premenstrual negative affect. In those switching from another pill, the menstrual-related distress symptoms remain stable.
Reproduced under CC-BY.
Topics
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