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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.

Moderate study design 126 women with PMDD across 10 centers in Sweden

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

Topics