PREMENSTRUAL MASTALGIA MedDRA version: 8.1 Level: LLT Classification code 10026876 Term: Mastalgia
Conditions
Interventions
Trade Name: FARESTON
Pharmaceutical Form: Tablet
INN or Proposed INN: TOREMIFENE CITRATE
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Sinikka Oksa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) a mastalgia severe enough to interfere with social life and to cause a desire to use medication against it, lasting for more than five days during the luteal phase of the menstrual cycle, 2) an at least three-month-history of symptoms, 3) age between 25 to 45 years, and 4) regular menstrual cycles. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Women using hormonal contraception or treatment, those reporting irregular menstrual cycles, history of breast or endometrial cancer, hysterectomy and/or bilateral oophorectomy, pregnancy, lactation or a desire for pregnancy, and those with serious health problems. Women with a history of thromboembolic disease were also excluded. Patients with pacemaker, metallic cardiac valve or endoprostheses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the changes in breast magnetic resonance imaging during toremifene and placebo treatment;Secondary Objective: To investigate the efficacy of toremifene in the treatment of premenstrual mastalgia quality of life;Primary end point(s): Primary end point: changes in breast magnetic resonance imaging during toremifene treatment, cyclic breast pain relief | — |
Countries
Finland
Outcome results
None listed