Changes in Breast 3D Ultrasound Measurements Using Toremi... | NCT01417754

Studies
Changes in Breast 3D Ultrasound Measurements Using Toremifene

NCT01417754

Sponsor

Satakunta Central Hospital

Status

Completed

Last Update Posted

Aug 23, 2011Estimated

Enrollment

20Actual

Phase

Phase 3

Conditions

Circulatory; Change

Interventions

Toremifene

Countries

Finland

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

Status Module

Record Verification Date

Aug 2011

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

Sep 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jul 28, 2011

First Submission Date that Met QC Criteria

Aug 15, 2011

First Posted Date

Aug 16, 2011Estimated

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

Aug 22, 2011

Last Update Posted Date

Aug 23, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

SINIKKA OKSA, MD, principal investigator, Satakunta Central HospitalPrincipal Investigator

Lead Sponsor

Satakunta Central HospitalOTHER

Collaborators

Name	Class
Tampere University Hospital	OTHER
Tampere University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate if there are detectable changes in volume and circulation in breasts of healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus nonmedicated cycle.

Detailed Description

20 women were participated to this trial.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Toremifene	Other		Drug: Toremifene

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Toremifene	Drug	20mg toremifene per day in tablet form starting from the cycle day 15 and continued to premenstrual period. Medication using about 10 days per volunteer	Toremifene

Measure	Description	Time Frame
circulation changes of the breast		cycle day 23 to 26

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 25-45 healthy person
regular menstrual cycles
safe contraception(for example sterilization or condom)

Exclusion Criteria:

gynecological or other type of cancer
hormonal contraception
pregnancy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 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

Name	Affiliation	Role
Sinikka Oksa, MD	Satakunta Central Hospital	Principal Investigator
Johanna Mäenpää, professor	Tampere University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Porin Lääkäritalo		Pori		28100	Finland

Intervention Browse Module

MeSH Terms

ID	Term
D017312	Toremifene

Ancestor Terms

ID	Term
D013629	Tamoxifen
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided