A study to evaluate the effectiveness and safety of study drug (sepranolone) in patients with premenstrual dysphoric disorder (PMDD)

Registry ID
EUCTR2017-000822-37
Source registry
EUCTR
Status
Completed
Phase
PHASE2
Sponsor
Asarina Pharma
Start date
2017-10-30
Completion date
2020-02-25
Last update
2026-08-16

Conditions

Summary

The primary objective of the study is to evaluate the effect of two doses of UC1010 on premenstrual symptoms in women with PMDD in comparison to placebo. The effect of UC1010 given repeatedly to women with PMDD as subcutaneous injections during the luteal phase of three consecutive menstrual cycles will be compared with a corresponding placebo administration. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale also used for the diagnosis of PMDD.

Locations

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