Efficacy and Safety of 20 mg (2 Tablets of 10mg)VAC BNO 1095 FCT on Cyclic Mastodynia and PMS
The purpose of this study is to proof the efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 film-coated tablets in patients suffering from cyclic mastodynia and PMS (pre menstrual syndrome).
Drug: 20mg VAC BNO 1095 FCT
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Prospective, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Randomized Clinical Trial to Proof Efficacy and Safety of 20 mg (2 Tablets of 10 mg) VAC BNO 1095 FCT in Patients Suffering From Cyclic Mastodynia and PMS|
- Maximum severity of cyclic breast pain [ Time Frame: after 3 months treatment under Investigational Medicinal Product (IMP). ] [ Designated as safety issue: No ]Maximum severity of cyclic breast pain after 3 months treatment under Investigational Medicinal Product (IMP). The severity of cyclic breast pain will be self-assessed by the patient on a Visual Analogue Scale (VAS).
- Severity of cyclic breast pain and PMS symptoms [ Time Frame: After 1, 2 and 3 months of treatment ] [ Designated as safety issue: No ]
- Maximum severity of cyclic breast pain after 1 and 2 months treatment, respectively. The severity of cyclic breast pain will be self-assessed by the patient on a VAS
- Average severity of cyclic mastodynia, determined in the late luteal phase of each of the treatment cycles.
- Intensity of PMS assessed by means of a PMS diary (COPE = calendar of premenstrual experiences) during each of the treatment cycles
- Overall assessments of efficacy on cyclic mastodynia and PMS by patient and investigator at study end by a score ranging from 1 to 5
- Subgroup analysis: A. Patients with the waist circumference ≤ 90 cm B. Patients with the waist circumference > 90 cm. For both subgroups A. and B.: Maximum severity of cyclic breast pain after 3 months treatment under IMP. The severity of cyclic breast pain will be self-assessed by the patient on a VAS.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: VAC BNO 1095 2x10 mg FCT
VAC BNO 1095 2x10 mg FCT 2 tablets of verum in the morning, oral, 3 months treatment
|Drug: 20mg VAC BNO 1095 FCT|
Placebo Comparator: Placebo
2 tablets in the morning, oral, 3 months treatment
The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening at S-2 further visits are scheduled after the end of each of the first and second run-in cycle, and after the first, second and third treatment cycle, respectively.
At least 220 patients should be eligible for randomisation, 110 to each treatment group, of which 160 (80 per group) will be available for data evaluation.
|Contact: Eugen Baumgärtner||0049 9181 231 email@example.com|
|Private Doctor's office - Dr. Hannes Herold||Recruiting|
|Munich, Bavaria, Germany, 80802|
|Contact: Hannes Herold, MD 004989347534 firstname.lastname@example.org|
|Study Chair:||Andrzej Witek, MD PhD Prof.|
|Study Chair:||Hannes Herold, Dr. med.|