A Phase I/II Study to Evaluate UC1010 Treatment in Premen... | NCT01875718

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

NCT01875718

Sponsor

Umecrine Mood AB

Status

Completed

Last Update Posted

Jan 21, 2015Estimated

Enrollment

146Estimated

Phase

Phase 1Phase 2

Conditions

Premenstrual Dysphoric Disorder

Interventions

UC1010
Placebo

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

May 29, 2013

First Submission Date that Met QC Criteria

Jun 11, 2013

First Posted Date

Jun 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2015

Last Update Posted Date

Jan 21, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

146Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
UC1010 low dose	Active Comparator	Drug: UC1010
UC1010 high dose	Active Comparator	Drug: UC1010
Vehicle	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UC1010	Drug		UC1010 high dose UC1010 low dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Premenstrual symptom severity		Daily Record of Severity of Problems (DRSP) measured during 4-5 months

Secondary Outcomes

Measure	Description	Time Frame
Number of subjects with adverse events		During 1.5 month (starting from first dose)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Umecrine Mood AB		Solna		17165	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D065446	Premenstrual Dysphoric Disorder

Ancestor Terms

ID	Term
D011293	Premenstrual Syndrome
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided