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Clinical Trials/EUCTR2017-000822-37-GB
EUCTR2017-000822-37-GB
Active, not recruiting
Phase 1

A phase II, randomised, double-blind, placebo-controlled, parallel-group, multi-centre study investigating efficacy and safety of Sepranolone (UC1010) in patients with PMDD

Asarina Pharma0 sites250 target enrollmentSeptember 18, 2017
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ConditionsPremenstrual dysphoric disorder (PMDD)MedDRA version: 20.0Level: PTClassification code 10051537Term: Premenstrual dysphoric disorderSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Premenstrual dysphoric disorder (PMDD)
Sponsor
Asarina Pharma
Enrollment
250
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 18, 2017
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Asarina Pharma

Eligibility 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

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.

Outcomes

Primary Outcomes

Not specified

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