Premenstrual Dysphoric Disorder
Conditions
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.
Interventions
DRUGSepranolone (UC1010) low dose
Subcutaneous (SC) administration
DRUGSepranolone (UC1010) high dose
Subcutaneous (SC) administration
DRUGPlacebo
Subcutaneous (SC) adminstration
Sponsors
Ergomed
Asarina Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Starting from first dose given until 1 months after treatment stop | Recording of adverse events |
Countries
Germany, Poland, Sweden, United Kingdom
Outcome results
None listed