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

NCT00534846 | Completed Phase 3

• 2 other identifiers: tore20mgEudraCT 2006-006109-97
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Pain

Keywords

premenstrual syndrome; mastalgia; toremifene; selective estrogen receptor modulators

Outcome Measures

Primary Outcomes (2)

• the effects to the MRI findings

  after three cycles toremifene and placebo plus wash-out cycle, seven months

• magnetic resonance imaging changes

  seven months

Secondary Outcomes (2)

• cyclic breast pain relief, quality of life, acceptability of treatment

  seven months

• breast pain

  seven months

Study Arms (2)

A placebo

PLACEBO COMPARATOR

The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.

Drug: placebo

B toremifene

ACTIVE COMPARATOR

The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.

Drug: toremifene

Interventions

toremifene DRUG

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.

Also known as: magnetic resonance imaging, cyclic breast pain

B toremifene

placebo DRUG

tablet equal to toremifene, one tablet daily from cycle day 15 to menstruation during three cycles

A placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Satakunta Central Hospital: lead
• Tampere University: collaborator

Study Sites (1)

Satakunta Central hospital, department of gynaecology and obstetrics

Pori, 28500, Finland

Location

Related Publications (1)

• Oksa S, Luukkaala T, Maenpaa J. Toremifene for premenstrual mastalgia: a randomised, placebo-controlled crossover study. BJOG. 2006 Jun;113(6):713-8. doi: 10.1111/j.1471-0528.2006.00943.x.

  PMID: 16709215 BACKGROUND

MeSH Terms

Conditions

Mastodynia; Premenstrual Syndrome

Interventions

Toremifene; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• SINIKKA OKSA, MD

  Satakunta Central Hospital

  PRINCIPAL INVESTIGATOR

• JOHANNA MÄENPÄÄ

  Tampere University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: February 1, 2009
• Last Updated: May 13, 2009

Record last verified: 2009-05

Locations

FI (1)