Adapted from Al-Hendy et al. 2023.1,2,4
Study Population1,2
Premenopausal women 18–50 with a diagnosis of uterine fibroids and heavy menstrual bleeding, with menstrual blood loss of >80 mL per cycle in two consecutive cycles or >160 mL in one cycle (alkaline haematin method)
Primary Endpoint1,2
Proportion of women who achieved or maintained a menstrual blood loss volume of less than 80 mL and at least a 50% reduction in menstrual blood loss volume from pivotal study baseline to the last 35 days of treatment
Key Secondary Endpoints1,2
- Reported amenorrhoea, over the last 35 days of treatment at Week 24 and 52
- Volume of menstrual blood loss, change vs baseline at Week 24 and 52
- Distress from bleeding and pelvic discomfort, change vs baseline at Week 24 and 52
- Anaemia, change in haemoglobin vs baseline at Week 24 and 52
- Pain (measured by numerical rating scale (NRS) score), over the last 35 days of treatment
- Primary fibroid volume, change vs baseline at Week 24 and 52
- Uterine volume, change vs baseline at Week 24 and 52
For more information on the SPIRIT studies please see the full publication
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References
- Al-Hendy A et al. N Engl J Med. 2021;384:630–42.
- Al-Hendy A et al. Obstet Gynecol. 2022;140:920–30.
- Al-Hendy A et al. Am J Obstet Gynecol. 2023;229:662.e1–25