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Low-dose ulipristal acetate is an effective treatment for PMDD

Presented by
Dr Erika Comasco, Uppsala University, Sweden
ECNP 2022
Phase 2
In a recent study, daily treatment with 5 mg ulipristal acetate significantly reduced symptoms in women with premenstrual dysphoric disorder (PMDD).

PMDD is a common mood disorder characterised by distressing affective, behavioural, and somatic symptoms in the late luteal phase of the menstrual cycle. The gold-standard treatment of PMDD is intermittent or continuous use of selective serotonin reuptake inhibitors (SSRIs), with varying success. Dr Erika Comasco (Uppsala University, Sweden) presented results from a study (EudraCT 2016-001719-19) that evaluated the efficacy of low-dose ulipristal acetate, a selective progesterone-receptor modulator, which maintains oestradiol on a mid-follicular level [1] .

The study randomised 95 women with PMDD 1:1 to receive ulipristal acetate (5 mg every day) or placebo for three 28-day treatment cycles. In women treated with ulipristal acetate, progesterone levels were significantly reduced. The mean improvement in Daily Record of Severity of Problems (DRSP) total score after 3 months was 41% in the ulipristal acetate arm versus 22% in the placebo arm (P=0.003); 58% of participants in the ulipristal acetate arm reached partial or total remission [2]. Symptom severity (DRSP subscales) of irritability, depression, anxiety, and affective lability were significantly decreased with ulipristal acetate.

Neuroimaging revealed an increase in fronto-cingulate reactivity during aggressive response in women receiving ulipristal acetate compared with placebo, suggesting higher top-down control [3]. No changes in grey matter structure were observed after ulipristal acetate treatment.

“These findings highlight an alternative treatment for PMDD and contribute to advance our understanding of PMDD from a mechanistic point of view,” concluded Dr Comasco.

  1. Comasco E, et al. Switching on and off mood symptoms: premenstrual dysphoric disorder as study model. Abstract S02.04, ECNP Congress 2022, 15–18 October, Vienna, Austria.
  2. Comasco E, et al. Am J Psych. 2021;178:256–265.
  3. Kaltsouni E, et al. Neuropsychopharmacology. 2021;46:1460–1467.


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