Changes in Breast 3D Ultrasound Measurements Using Toremifene
This study has been completed.
Sponsor:
Satakunta Central Hospital
Collaborators:
Tampere University Hospital
University of Tampere
Information provided by (Responsible Party):
SINIKKA OKSA, Satakunta Central Hospital
ClinicalTrials.gov Identifier:
NCT01417754
First received: July 28, 2011
Last updated: August 22, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Circulatory; Change |
Drug: Toremifene |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Volume and Circulation Changes of The Breast in 3D Ultrasound During Toremifene Versus Nonmedicated Menstrual Cycle |
Resource links provided by NLM:
MedlinePlus related topics:
Menstruation
Drug Information available for:
Toremifene citrate
U.S. FDA Resources
Further study details as provided by Satakunta Central Hospital:
Primary Outcome Measures:
- circulation changes of the breast [ Time Frame: cycle day 23 to 26 ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | September 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Toremifene |
Drug: Toremifene
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
Other Name: trade name Fareston
|
Detailed Description:
20 women were participated to this trial.
Eligibility| Ages Eligible for Study: | 25 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417754
Locations
| Finland | |
| Porin Lääkäritalo | |
| Pori, Finland, 28100 | |
Sponsors and Collaborators
Satakunta Central Hospital
Tampere University Hospital
University of Tampere
Investigators
| Principal Investigator: | Sinikka Oksa, MD | Satakunta Central Hospital |
| Study Director: | Johanna Mäenpää, professor | Tampere University Hospital |
More Information
No publications provided
| Responsible Party: | SINIKKA OKSA, MD, principal investigator, Satakunta Central Hospital |
| ClinicalTrials.gov Identifier: | NCT01417754 History of Changes |
| Other Study ID Numbers: | Tore3D |
| Study First Received: | July 28, 2011 |
| Last Updated: | August 22, 2011 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by Satakunta Central Hospital:
|
toremifene |
Additional relevant MeSH terms:
|
Toremifene Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators |
Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013