A Multicentre, Double-blind, Placebo-Controlled, Parallel Group Study of the Effect of Oral Etamsylate (Dicynone®) in Patients with Menorrhagia - Effects of Oral Etamsylate in Patients with Menorrhagia

Conditions: Menorrhagia in patients with regular menstrual cycle
MedDRA version: 12.0Level: LLTClassification code 10027313Term: Menorrhagia

Registration Number: EUCTR2009-013485-23-PT

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 and placebo on the reduction of menstrual blood loss (MBL) in patients with menorrhagia.<br><br>Menstrual blood loss (MBL) during the 3rd treatment cycle, measured by the alkaline haematin method;Secondary Objective: The secondary efficacy objectives include:<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>The secondary safety objectives include:<br><br>- Physical examination<br>- Vital signs<br>- Safety laboratory<br>- Adverse events and serious adverse events;Primary end point(s): Menstrual blood loss (MBL) during the 3rd treatment cycle, measured by the alkaline haematin method

Secondary Outcome Measures