- Uninterrupted asoprisnil treatment for 12 months is highly effective in controlling bleeding, reducing fibroid and uterine volume and improving anaemia and health-related quality-of life (HRQoL) in women with heavy menstrual bleeding (HMB) associated with uterine fibroids with acceptable safety profile.
- However, asoprisnil treatment led to an increase in endometrial thickness and invasive diagnostic and therapeutic procedures, with potential
Why this matters
- In 3-month phase 2 study, asoprisnil showed dose-dependent reduction in HMB, fibroid and uterine volume and improvement in haematological parameters in women with HMB associated with uterine fibroids with acceptable safety and tolerability profile.
- This pooled analysis of two phase 3, placebo-controlled, randomised trials included 907 women who were randomly assigned (2:2:1) to orally receive 10 mg (n=370) and 25 mg (n=364) asoprisnil and placebo (n=173).
- Primary endpoint: ≥50% reduction in monthly blood loss (MBL), haemoglobin levels ≥11 g/dL or ≥1 g/dL and no surgical or invasive intervention at 12 months.
- Funding: AbbVie Inc.
- Compared with placebo (35%), most of the women in the asoprisnil 10- (90%) and 25-mg (93%) groups achieved the primary endpoint at 6 and 12 months (P<.001>
- At 6 and 12 months, haemoglobin level rapidly increased with asoprisnil and was significantly higher than placebo group throughout the treatment (P<.001>
- Asoprisnil group showed significant reduction in primary fibroid and uterine volumes, MBL and number of days with bleeding and with bleeding or spotting vs placebo group (P<.001 for all>
- There was a significant improvement in uterine fibroid symptom severity score and HRQoL with asoprisnil vs placebo group (P<.001>
- At month 6, mean endometrial thickness at month 12 increased by ~2 mm in both asoprisnil groups compared with placebo (P<.01>
- Most study participants were black.
- Insufficient study duration to determine the endometrial effects.