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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Umecrine Mood AB
ClinicalTrials.gov Identifier:
NCT01875718
First received: May 29, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Premenstrual Dysphoric Disorder
Drug: UC1010
Drug: Placebo
Phase 1
Phase 2

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

Further study details as provided by Umecrine Mood AB:

Primary Outcome Measures:
  • Premenstrual symptom severity [ Time Frame: Daily Record of Severity of Problems (DRSP) measured during 4-5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: During 1.5 month (starting from first dose) ]

Estimated Enrollment: 146
Study Start Date: January 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: UC1010 low dose Drug: UC1010
Active Comparator: UC1010 high dose Drug: UC1010
Placebo Comparator: Vehicle Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875718

Locations
Sweden
Umecrine Mood AB
Solna, Sweden, 17165
Sponsors and Collaborators
Umecrine Mood AB
  More Information

No publications provided

Responsible Party: Umecrine Mood AB
ClinicalTrials.gov Identifier: NCT01875718     History of Changes
Other Study ID Numbers: UM104
Study First Received: May 29, 2013
Last Updated: April 10, 2014
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014