Premenstrual dysphoric disorder (PMDD) MedDRA version: 20.0 Level: PT Classification code 10051537 Term: Premenstrual dysphoric disorder System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Sepranolone
Product Code: UC1010
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Sepranolone
CAS Number: 516-55-2
Current Sponsor code: UC1010
Co
Sponsors
Asarina Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must: ? be a woman between 18-45 years of age ? have a regular menstrual cycle of 24-35 days cycle ? use double barrier contraception, non-hormonal IUD, be abstinent or surgically sterilized ? have PMDD according to DSM-5 verified in two menstrual cycles Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Most important criteria. Subjects must not: ? have any steroid hormonal treatment (including hormonal IUD, vaginal ring, cream or dermal patch) during the previous 3 months before the first study visit, ? have been treated with any psychopharmaceuticals during the previous 3 months before the first study visit, unless for SSRI where 1 month wash-out time is acceptable, ? have treatment during the previous 3 months before the first study visit with over-the-counter or prescription drugs for PMS symptoms, ? have a significant medical condition ongoing in the opinion of the investigator, including any chronic psychiatric disease with a relapse in the past year, ? have a drug or alcohol, abuse or dependency, ongoing or have a history of such abuse or dependency during the last 2 years, ? be pregnant, given birth within the last 4 months before the first study visit, be breast-feeding or intending to become pregnant during the study period, ? have a clinically relevant finding on the physical examination or blood testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effect of two doses of UC1010 on premenstrual symptoms in women with PMDD in comparison to placebo. The effect of UC1010 given repeatedly to women with PMDD as subcutaneous injections during the luteal phase of three consecutive menstrual cycles will be compared with a corresponding placebo administration. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale also used for the diagnosis of PMDD. ;Secondary Objective: The secondary objective of the study is to evaluate safety and tolerability of repeated subcutaneous administration of UC1010;Primary end point(s): Primary analysis will be change from baseline in late luteal phase Total symptom score (LmaxSum21) determined as the average sum score of all 21 questions (Q) recorded during the worst 5 consecutive days during Day -6 to Day 1. The DRSP variables will be calculated as the difference between the average of two diagnostic cycles (D) and the average of the two last treatment cycles in the UC1010-treated (A), and in placebo-treated patients (P), i.e. Lmax (D-A vs. D-P). Only ovulatory cycles (confirmed by elevated progesterone levels) will be used for assessment of treatment effects. ;Timepoint(s) of evaluation of this end point: During treatment: -during the worst 5 consecutive days during Day -6 to Day 1 for each patient -during ovulatory cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The corresponding Lmax for the Impairment score, i.e. sum scores of Q22-24 (Lmax Impairment) will be calculated accordingly. The corresponding Lmax for the PMDD cardinal symptom score, i.e. sum Q1-8 (Lmax Sum1a4b) including depression, anxiety, lability and anger/irritability scores will be calculated accordingly. Symptom severity will be assessed using the CGI-S scale, and change in symptom severity from baseline to after completion of the three treatment cycles will be assessed using the CGI-I scale where subjects with a score of 1 (very much improved) or 2 (much improved) are defined as responders.;Timepoint(s) of evaluation of this end point: During treatment | — |
Countries
Germany, Poland, Sweden, United Kingdom, United States
Contacts
Public ContactKarin Ekberg
Asarina Pharma
Outcome results
None listed