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

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ClinicalTrials.gov Identifier: NCT01875718
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Umecrine Mood AB

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.


Condition or disease Intervention/treatment Phase
Premenstrual Dysphoric Disorder Drug: UC1010 Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: UC1010 low dose Drug: UC1010
Active Comparator: UC1010 high dose Drug: UC1010
Placebo Comparator: Vehicle Drug: Placebo



Primary Outcome Measures :
  1. Premenstrual symptom severity [ Time Frame: Daily Record of Severity of Problems (DRSP) measured during 4-5 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875718


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

Responsible Party: Umecrine Mood AB
ClinicalTrials.gov Identifier: NCT01875718     History of Changes
Other Study ID Numbers: UM104
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Premenstrual Dysphoric Disorder
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Depressive Disorder
Mood Disorders
Mental Disorders