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.
| Autor: | Bitzer J; Department of Obstetrics and Gynaecology, University Hospital of Basel, Basel, Switzerland., Bouchard C; Clinique de Recherche en Santé des Femmes, Québec, Canada., Zatik J; Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo, Debrecen, Hungary., Weyers S; Department of Obstetrics and Gynaecology, Ghent University Hospital, Ghent, Belgium., Piltonen T; Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Centre, Oulu University Hospital, Oulu, Finland., Suturina L; Department of Reproductive Health Protection, Scientific Center for Family Health and Human Reproduction, Irkutsk, Russian Federation., Apolikhina I; National Medical Research Center for Obstetrics, Gynaecology and Perinatology named after Academician V.I. Kulakov, Ministry of Healthcare of Russia, Moscow, Russia., Gemzell-Danielsson K; Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden., Jost M; Estetra SRL, an affiliate company of Mithra Pharmaceuticals, Liège, Belgium., Creinin MD; Department of Obstetrics and Gynecology, University of CA, Sacramento, California, USA., Foidart JM; Department of Gynaecology and Obstetrics, University of Liège, Liège, Belgium. |
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| Jazyk: | angličtina |
| Zdroj: | The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception [Eur J Contracept Reprod Health Care] 2024 Aug; Vol. 29 (4), pp. 150-159. Date of Electronic Publication: 2024 Jun 21. |
| DOI: | 10.1080/13625187.2024.2359117 |
| Abstrakt: | 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 < 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. |
| Databáze: | MEDLINE |
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