A Multicentre, Double-blind, Placebo-Controlled, Parallel Group Study of the Effect of Oral Etamsylate (Dicynone®) in Patients with Menorrhagia
- Conditions
- Menorrhagia in patients with regular menstrual cycleMedDRA version: 12.0Level: LLTClassification code 10027313Term: Menorrhagia
- Registration Number
- EUCTR2009-013485-23-DE
- Lead Sponsor
- OM PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 230
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of etamsylate when compared with placebo on the reduction of menstrual blood loss in patients with menorrhagia.<br><br>PRIMARY EFFICACY VARIABLE:<br><br>Menstrual blood loss (MBL) during the 3rd treatment cycle, measured by the alkaline haematin method.<br>;Secondary Objective: SECONDARY EFFICACY VARIABLES<br><br>·Mean values per cycle of MBL during the 3 relevant cycles assessed by the<br> menstrual pictogram<br>·Number of days of menstrual flow for the 3 cycles<br>·Blood haemoglobin, S-ferritin<br>·Type and duration of prescribed concomitant treatment(s)<br>·Global assessment of efficacy and quality of life by patient and investigator<br><br>;Primary end point(s): Menstrual blood loss (MBL) during the 3rd treatment cycle, measured by the alkaline haematin method
- Secondary Outcome Measures
Name Time Method