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Clinical Trials/NCT01875718
NCT01875718
Completed
Phase 1

A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women (Part 1) and Multiple Dosing in PMDD Women (Part 2) - Phase I/II Study

Umecrine Mood AB1 site in 1 country146 target enrollmentJanuary 2013

Overview

Phase
Phase 1
Intervention
UC1010
Conditions
Premenstrual Dysphoric Disorder
Sponsor
Umecrine Mood AB
Enrollment
146
Locations
1
Primary Endpoint
Premenstrual symptom severity
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1.

In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Umecrine Mood AB
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Part 1 -Essentially healthy
  • Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles

Exclusion Criteria

  • steroid hormonal treatment during the previous three months
  • treatment with psychopharmaceuticals or other treatment for PMS
  • history of or a significant medical condition ongoing
  • be pregnant or plan a pregnancy within the study period

Arms & Interventions

UC1010 low dose

Intervention: UC1010

UC1010 high dose

Intervention: UC1010

Vehicle

Intervention: Placebo

Outcomes

Primary Outcomes

Premenstrual symptom severity

Time Frame: Daily Record of Severity of Problems (DRSP) measured during 4-5 months

Secondary Outcomes

  • Number of subjects with adverse events(During 1.5 month (starting from first dose))

Study Sites (1)

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