NCT01417754

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_3

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

September 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

2 months

First QC Date

July 28, 2011

Last Update Submit

August 22, 2011

Conditions

Circulatory; Change

Keywords

toremifene

Outcome Measures

Primary Outcomes (1)

  • circulation changes of the breast

    cycle day 23 to 26

Study Arms (1)

Toremifene

OTHER
Drug: Toremifene

Interventions

ToremifeneDRUG

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

Also known as: trade name Fareston
Toremifene

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • gynecological or other type of cancer
  • hormonal contraception
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Porin Lääkäritalo

Pori, 28100, Finland

Location

MeSH Terms

Interventions

Toremifene

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sinikka Oksa, MD

    Satakunta Central Hospital

    PRINCIPAL INVESTIGATOR

  • Johanna Mäenpää, professor

    Tampere University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, principal investigator

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 16, 2011

Study Start

September 1, 2010

Primary Completion

November 1, 2010

Study Completion

June 1, 2011

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

FI(1)