Randomised trial, 2017
Does Sepranolone reduce symptoms of severe premenstrual syndrome (PMDD)?
Yes, Sepranolone reduced PMDD symptoms significantly more than placebo, with severe symptom scores dropping by 75% compared to 47% for placebo in women who completed treatment correctly. However, implementation challenges limit confidence in the results.
What they did
This was a two-part study across 10 Swedish centers. First, 26 healthy women tested the drug's safety and dosing. Then 126 women with PMDD were randomly assigned to receive Sepranolone (10 or 16mg injected under the skin every other day during the luteal phase) or placebo for one menstrual cycle.
What they found
Of 126 women, 106 completed the study. Sepranolone reduced total symptoms significantly more than placebo (p=0.041). Mood symptoms showed borderline significance (p=0.051). In the subgroup of 60 women with pure PMDD who took medication correctly, Sepranolone reduced symptom scores by 75% compared to 47% with placebo.
What it means for you
Sepranolone appears to reduce PMDD symptoms significantly when injected during the luteal phase. However, 19 women showed symptoms at the wrong time suggesting other conditions, and 27 did not take medication correctly. Larger, better-controlled studies are needed before it can be used routinely.
126
women with PMDD enrolled
75%
symptom reduction with Sepranolone in subset
47%
symptom reduction with placebo in subset
About the study
- Original title
- Treatment of premenstrual dysphoric disorder with the GABA A receptor modulating steroid antagonist Sepranolone (UC1010)-A randomized controlled trial
- Authors
- Bixo M, Ekberg K, Poromaa IS et al.
- Journal
- Psychoneuroendocrinology
- Year
- 2017
- Study design
- Randomised trial
- Participants
- 60
- What was tested
- Sepranolone (UC1010) 10 or 16mg injected under the skin every other day during the luteal phase
- Open access
- Yes
- Read the paper
- doi.org/10.1016/j.psyneuen.2017.02.031
Topics
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