Menorrhagia in patients with regular menstrual cycle MedDRA version: 12.0 Level: LLT Classification code 10027313 Term: Menorrhagia
Conditions
Interventions
Trade Name: Dicynone
Pharmaceutical Form: Capsule, hard
CAS Number: 0
Other descriptive name: ETAMSYLATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharma
Sponsors
OM PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Females aged = 18 to = 50, with excessive menstrual blood loss of = 80 to = 250 mL per menstruation and regular menstrual cycle. 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: Patients with systemic pathology which can influence haemostasis, patients with complex hyperplasia with or w/o atypia, endometrial carcinoma, severe adenomyosis or with submucous fibroids, patients with uterine cavity > 10 weeks of pregnancy size, patients pregnant or lactating and unreliable patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of etamsylate when compared with placebo on the reduction of menstrual blood loss in patients with menorrhagia. PRIMARY EFFICACY VARIABLE: Menstrual blood loss (MBL) during the 3rd treatment cycle, measured by the alkaline haematin method. ;Secondary Objective: SECONDARY EFFICACY VARIABLES · Mean values per cycle of MBL during the 3 relevant cycles assessed by the menstrual pictogram · Number of days of menstrual flow for the 3 cycles · Blood haemoglobin, S-ferritin · Type and duration of prescribed concomitant treatment(s) · Global assessment of efficacy and quality of life by patient and investigator ;Primary end point(s): Menstrual blood loss (MBL) during the 3rd treatment cycle, measured by the alkaline haematin method | — |
Countries
France, Germany, Portugal
Outcome results
None listed