Exit Interviews Examining Changes to Mood and Work/Productivity Impacts Related to Vasomotor Symptoms: Perspectives of Postmenopausal Women Receiving Elinzanetant in Phase III Clinical Trials.

BACKGROUND: Vasomotor symptoms (VMS; hot flashes) significantly impact women's health-related quality of life during the menopausal transition. Two phase III trials (OASIS 1 and 2) were conducted to investigate the efficacy and safety of elinzanetant for the treatment of moderate-to-severe VMS associated with menopause. This exit interview study explored the impact of VMS on women's mood and work/productivity before and since treatment. METHODS: A total of 40 postmenopausal women from the USA who participated in OASIS 1 and 2 (receiving elinzanetant for 26 weeks or placebo for 12 weeks followed by elinzanetant for 14 weeks) took part in a 60-min exit interview. Interviews were conducted via telephone by trained qualitative interviewers using a semi-structured interview guide; concept-elicitation techniques, followed by focused questioning, were used to explore concepts of interest. Interview transcripts were analyzed using thematic analysis methods in Atlas.ti. Saturation analysis was conducted to determine the appropriateness of the sample size. RESULTS: Twelve mood concepts and seven work/productivity concepts were reported to be associated with VMS before taking the study medication. Most commonly reported mood concepts included reduced happiness (60.0%), embarrassment (50.0%), and mood swings (45.0%). Most commonly reported work/productivity concepts included reduced concentration (77.5%) and reduced productivity (67.5%). Most participants reported improvements since taking the study medication (mood: ≥ 82.4%; work/productivity: ≥ 80.0%), which contributed to other positive changes (e.g., in social wellbeing). Improvements were considered meaningful (≥ 72.2%) and highly satisfying (≥ 71.4%). CONCLUSION: This study provides novel insights into women's experiences of VMS-associated impacts on mood and work/productivity, highlighting the emotional and economic burdens of VMS. Data support and contextualize the treatment benefits of elinzanetant on mood and work/productivity that are meaningful to women.