Clinical trial NCT03697265: A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premenstrual Dysphoric Disorder
Lead sponsor: Asarina Pharma
Sponsor class: INDUSTRY
Collaborators: name: Ergomed
First posted: 2018-10-05
Enrollment: 475
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this phase IIb study is to evaluate the effect and safety of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD). Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms. Sepranolone is an endogenous steroid.

Detailed description: The objective of this phase IIb study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) in comparison to placebo, administrated during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms and impairment of symptoms on daily life of the patients. The scale is Daily Record of Severity of Problems (DRSP). Preceding the treatment period, the diagnosis of PMDD will be established in the study participants by at lest two menstrual cycles of prospective DRSP ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The Total symptom score of the DRSP will constitute the primary variable and the late luteal phase ratings in the respective menstrual cycles, before and during treatment, will be used.

The study will also include a follow-up (no treatment) cycle before patients final visit.

The study is conducted in four European countries (Sweden, Germany, Poland and United Kingdom) and will include up to 225 patients.

Eligibility criteria: Main Inclusion Criteria:

* have PMDD according to DSM-5 verified in two menstrual cycles
* have a regular menstrual cycle of 24-35 days cycle,
* use double barrier contraception, non-hormonal IUD, be truly sexually abstinent, or subject or her partner has been surgically sterilized,

Main Exclusion Criteria:

* steroid hormonal treatment or treatment with psychopharmaceuticals during previous three months
* treatments for premenstrual syndrome (PMS) or PMDD
* history of or significant medical condition ongoing
* be pregnant or plan a pregnancy within the study period

Primary outcomes:
measure: Effect on DRSP Total symptom score
timeFrame: Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment.
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Starting from first dose given until 1 months after treatment stop
Other outcomes:
Locations:
city: Bad Homburg
country: Germany
facility: Zentrum für Klinische Forschnung
city: Berlin
country: Germany
facility: Emovis
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
city: Karlsruhe
country: Germany
facility: Klinische Forschung Karlsruhe GmbH
city: Nürnberg
country: Germany
facility: Praxis Dr. Steinwachs
city: Elbląg
country: Poland
facility: Centrum Kliniczno-Badawcze
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Kraków
country: Poland
facility: ProCreative
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Women's NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College London
city: Stoke-on-Trent
country: United Kingdom
facility: Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire
Study officials:
affiliation: Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire
name: Shaughn O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bixo M, Ekberg K, Poromaa IS, Hirschberg AL, Jonasson AF, Andreen L, Timby E, Wulff M, Ehrenborg A, Backstrom T. Treatment of premenstrual dysphoric disorder with the GABAA receptor modulating steroid antagonist Sepranolone (UC1010)-A randomized controlled trial. Psychoneuroendocrinology. 2017 Jun;80:46-55. doi: 10.1016/j.psyneuen.2017.02.031. Epub 2017 Mar 1.