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1,038 results on '"Dysmenorrhea"'

13. 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

Author

Bitzer, Johannes, Bouchard, Céline, Zatik, János, Weyers, Steven, Piltonen, Terhi, Suturina, Larisa, Apolikhina, Inna, Gemzell-Danielsson, Kristina, Jost, Maud, Creinin, Mitchell D, and Foidart, Jean-Michel

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Behavioral and Social Science, Clinical Trials and Supportive Activities, Chronic Pain, Pain Research, Humans, Female, Adult, Russia, Young Adult, Premenstrual Syndrome, Europe, Androstenes, Self Report, Middle Aged, Adolescent, Drug Combinations, Surveys and Questionnaires, Dysmenorrhea, Estetrol, E4, E4/drsp, combined oral hormone contraception, menstrual distress questionnaire, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine
Abstract

PurposeTo describe the effects of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg on physical and emotional premenstrual and menstrual symptoms.Materials and methodsWe 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.ResultsOf 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 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).ConclusionE4/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.

Published
2024

33. Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study.

Author

Becker, Christian, Johnson, Neil, As-Sanie, Sawsan, Arjona Ferreira, Juan, Abrao, Mauricio, Wilk, Krzysztof, Imm, So, Mathur, Vandana, Perry, Julie, Wagman, Rachel, and Giudice, Linda

Subjects
dysmenorrhea, dyspareunia, endometriosis, long-term treatment, non-menstrual pelvic pain, pain, relugolix, Humans, Female, Adolescent, Young Adult, Adult, Middle Aged, Endometriosis, Dysmenorrhea, Dyspareunia, Quality of Life, Pelvic Pain, Analgesics, Opioid, Phenylurea Compounds, Pyrimidinones
Abstract

STUDY QUESTION: What is the efficacy and safety of long-term treatment (up to 2 years) with relugolix combination therapy (CT) in women with moderate to severe endometriosis-associated pain? SUMMARY ANSWER: For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis; after an initial decline of

Published
2024

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