A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)

Premenstrual Dysphoric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875718
• Other study ID #: UM104
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 29, 2013
• Last updated: January 19, 2015
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Umecrine Mood AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Dysphoric Disorder

Intervention

Drug:
• UC1010

• Placebo

Locations

Country	Name	City	State
Sweden	Umecrine Mood AB	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Umecrine Mood AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premenstrual symptom severity		Daily Record of Severity of Problems (DRSP) measured during 4-5 months	No
Secondary	Number of subjects with adverse events		During 1.5 month (starting from first dose)