UM203
Research type
Research Study
Full title
A phase II, randomised, double-blind, placebo-controlled, parallel-group, multicentre study investigating the efficacy and safety of Sepranolone (UC1010) in patients with PMDD
IRAS ID
225917
Contact name
Karin Ekberg
Contact email
Sponsor organisation
Asarina Pharma
Eudract number
2017-000822-37
Duration of Study in the UK
1 years, 7 months, 23 days
Research summary
Negative mood disturbance during the premenstrual phase of the menstrual cycle is caused by the metabolite allopregnanolone via its effects on the GABA receptor (transmits signals to the brain), for which women with Premenstrual Dysphoric Disorder (PMDD) have an increased sensitivity to.
UC1010, Sepranolone has been shown to regulate the effect of allopregnanolone on the GABA receptor. A previous explorative study with UC1010 resulted in reduction of premenstrual symptoms and impairment on daily life of women with PMDD.
The present study will be a controlled study with two UC1010 dose and one placebo (dummy) groups. In total 250 women with defined PMDD will be assigned randomly into one of the three treatment groups. This study is double blinded, neither the woman or the doctor will know what treatment is given.
Patients will be recruited primarily via advertisement in newspapers and in social media, but also via the hospitals and GP referrals to the hospitals. The study includes an initial diagnostic part lasting at least two full menstrual cycles in order to rate patients symptoms using a validated PMDD scale in an electronic patient diary. If patients fulfil the strict criteria of PMDD, they will be able to take part in the study.
The study medication will be taken as a single injection once every other day during the luteal phase of three consecutive menstrual cycles. The study medication is prefilled in single-use syringes for self-administration by patient and the injections should be given into the tummy, just under the skin. Appropriate training will be given by the clinical site staff during visits. During the treatment visits at the hospitals or by phone are planned.
The treatment period is followed by one menstrual cycle of non-treatment as a follow-up cycle.
The total participation per patient will last up to 7-8 months.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0300
Date of REC Opinion
17 Oct 2017
REC opinion
Further Information Favourable Opinion