A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)

Asarina Pharma

Status and phase: Completed; Phase 2

Conditions: Premenstrual Dysphoric Disorder

Treatments: Drug: Sepranolone (UC1010) low dose; Drug: Sepranolone (UC1010) high dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03697265

UM203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 475 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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475 participants in 3 patient groups, including a placebo group

Sepranolone (UC1010) low dose

Experimental group

Description:

Sepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase

Treatment:

Drug: Sepranolone (UC1010) low dose

Sepranolone (UC1010) high dose

Experimental group

Description:

Sepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase

Treatment:

Drug: Sepranolone (UC1010) high dose

Placebo

Placebo Comparator group

Description:

Placebo administered subcutaneously (SC) during the luteal phase

Treatment:

Drug: Placebo