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

The Effect of Toremifene Treatment to the Magnetic Resonance Imaging Findings in Women Suffering From Premenstrual Mastalgia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00534846

Enrollment

Registered

2007-09-26

Start date

2007-04-30

Completion date

2009-02-28

Last updated

2009-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Pain

Keywords

premenstrual syndrome, mastalgia, toremifene, selective estrogen receptor modulators

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.

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.

Interventions

DRUGtoremifene

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.

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
cyclic breast pain relief, quality of life, acceptability of treatment	seven months
breast pain	seven months

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026