NCT01875718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

1.4 years

First QC Date

May 29, 2013

Last Update Submit

January 19, 2015

Conditions

Premenstrual Dysphoric Disorder

Outcome Measures

Primary Outcomes (1)

  • Premenstrual symptom severity

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

Secondary Outcomes (1)

  • Number of subjects with adverse events

    During 1.5 month (starting from first dose)

Study Arms (3)

UC1010 low dose

ACTIVE COMPARATOR
Drug: UC1010

UC1010 high dose

ACTIVE COMPARATOR
Drug: UC1010

Vehicle

PLACEBO COMPARATOR
Drug: Placebo

Interventions

UC1010DRUG
UC1010 high doseUC1010 low dose
PlaceboDRUG
Vehicle

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umecrine Mood AB

Solna, 17165, Sweden

Location

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Premenstrual SyndromeMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 12, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

SE(1)