A study to evaluate the effectiveness and safety of study drug (sepranolone) in patients with premenstrual dysphoric disorder (PMDD)

Phase 1

• Conditions: Premenstrual dysphoric disorder (PMDD); MedDRA version: 21.1Level: PTClassification code 10051537Term: Premenstrual dysphoric disorderSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-000822-37-DE
• Lead Sponsor: Asarina Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-20
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 250

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified