A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)
- Conditions
- Premenstrual Dysphoric Disorder
- Interventions
- Registration Number
- NCT03697265
- Lead Sponsor
- Asarina Pharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 475
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered subcutaneously (SC) during the luteal phase Sepranolone (UC1010) high dose Sepranolone (UC1010) high dose Sepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase Sepranolone (UC1010) low dose Sepranolone (UC1010) low dose Sepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase
- Primary Outcome Measures
Name Time Method Effect on DRSP Total symptom score Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment. Change in DRSP Total symptom score (Daily Record of Severity of Problems) measured during the luteal phase (i.e. the week before menstruation) before and during treatment
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events Starting from first dose given until 1 months after treatment stop Recording of adverse events
Trial Locations
- Locations (12)
Medizentrum Essen Borbeck
🇩🇪Essen, Germany
Emovis
🇩🇪Berlin, Germany
Zentrum für Klinische Forschnung
🇩🇪Bad Homburg, Germany
Klinische Forschung Karlsruhe GmbH
🇩🇪Karlsruhe, Germany
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
ProCreative
🇵🇱Kraków, Poland
Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire
🇬🇧Stoke-on-Trent, United Kingdom
Centrum Kliniczno-Badawcze
🇵🇱Elbląg, Poland
Liverpool Women's NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Imperial College London
🇬🇧London, United Kingdom
Praxis Dr. Steinwachs
🇩🇪Nürnberg, Germany