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The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia

This study has been completed.
Sponsor:
Collaborator:
University of Tampere
Information provided by:
Satakunta Central Hospital
ClinicalTrials.gov Identifier:
NCT00534846
First received: September 24, 2007
Last updated: May 12, 2009
Last verified: May 2009
History of Changes
  Purpose

The purpose of this study is to determine the effect of toremifene treatment to the MRI findings of the breast in women suffering from premenstrual mastalgia.


Condition Intervention Phase
Breast Pain
 Drug: toremifene
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Toremifene Treatment to the Magnetic Resonance Imaging Findings in Women Suffering From Premenstrual Mastalgia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Satakunta Central Hospital:

Primary Outcome Measures:
  • the effects to the MRI findings [ Time Frame: after three cycles toremifene and placebo plus wash-out cycle, seven months ] [ Designated as safety issue: No ]
  • magnetic resonance imaging changes [ Time Frame: seven months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cyclic breast pain relief, quality of life, acceptability of treatment [ Time Frame: seven months ] [ Designated as safety issue: No ]
  • breast pain [ Time Frame: seven months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 2007
Study Completion Date: February 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A placebo
The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.
 Drug: placebo
tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles
Active Comparator: B toremifene
The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.
 Drug: toremifene
The medication is given in tablet form, and the participants are instructed to take one tablet daily from cycle day 15 until the next menstruation. The active (toremifene 20 mg) and control (placebo) tablets were identical in appearance.
Other Names:
  • magnetic resonance imaging
  • cyclic breast pain

Detailed Description:

Benign breast pain is a common complaint of women in western countries. As many as 41-69% of women reported having mastalgia sufficient to interfere with their daily routines. Approximately 8-10% of premenopausal women suffer monthly from moderate to severe breast pain.Tamoxifen has previously been found to be effective in reducing premenstrual mastalgia. We showed that another triphenylethylene derivative, toremifene, significantly alleviated cyclical breast pain as compared to placebo. In this study women suffering from cyclical breast pain are randomly allocated to receive toremifene (20mg) or placebo during the luteal phase for three consecutive cycles. The patients are then crossed over after a wash-out period to placebo or toremifene, respectively. The MRI investigations are made at two occasions during the premenstrual period after three cycles of toremifene and after three cycles of placebo.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Premenstrual mastalgia
  • Age 20-45 years
  • Reliable non-hormonal contraception

Exclusion Criteria:

  • Pregnancy
  • Breast cancer or uterine corpus cancer
  • Unexplained menstrual disorders
  • Serious health problems
  • Hormonal contraception, including hormonal IUD trade name Mirena
  • Oestrogen and/or progestin treatment
  • Hysterectomy and/or oophorectomy or radiation therapy
  • Artificial cardiac pacemaker/metallic prostheses
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534846

Locations
Finland
Satakunta Central hospital, department of gynaecology and obstetrics
Pori, Finland, 28500
Sponsors and Collaborators
Satakunta Central Hospital
University of Tampere
Investigators
Principal Investigator: SINIKKA OKSA, MD Satakunta Central Hospital
Study Director: JOHANNA MÄENPÄÄ Tampere University Hospital
  More Information

Publications:

Responsible Party: Sinikka Oksa, Satakunta Central Hospital
ClinicalTrials.gov Identifier: NCT00534846     History of Changes
Other Study ID Numbers: tore20mg, EudraCT 2006-006109-97
Study First Received: September 24, 2007
Last Updated: May 12, 2009
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Satakunta Central Hospital:
premenstrual syndrome
mastalgia
toremifene
selective estrogen receptor modulators

Additional relevant MeSH terms:
Toremifene
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 17, 2013