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.
Eur J Contracept Reprod Health Care
; 29(4): 150-159, 2024 Aug.
Article
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| MEDLINE
| ID: mdl-38904165
ABSTRACT
PURPOSE:
To describe the effects of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg on physical and emotional premenstrual and menstrual symptoms. MATERIALS ANDMETHODS:
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 < 0.01). For switchers, no changes were significant except an increase in premenstrual (+1.0, 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.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Síndrome Premenstrual
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Autoinforme
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Androstenos
Límite:
Adolescent
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Adult
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Female
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Humans
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Middle aged
País/Región como asunto:
Asia
/
Europa
Idioma:
En
Revista:
Eur J Contracept Reprod Health Care
Asunto de la revista:
MEDICINA REPRODUTIVA
/
SERVICOS DE PLANEJAMENTO FAMILIAR
Año:
2024
Tipo del documento:
Article
País de afiliación:
Suiza