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NCT Number: NCT01875718

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

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.

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Key information

Conditions

Premenstrual Dysphoric Disorder Depressive Disorder Menstruation Disturbances Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Umecrine Mood AB

Solna, 17165, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UC1010

Drug

Placebo

Drug

Primary outcomes

  1. Premenstrual symptom severity

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

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: During 1.5 month (starting from first dose)

Sponsors and collaborators

Lead sponsor

Umecrine Mood AB

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2013
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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