Efficacy and Safety of 20 mg (2 Tablets of 10mg)VAC BNO 1095 FCT on Cyclic Mastodynia and PMS
|ClinicalTrials.gov Identifier: NCT01870687|
Recruitment Status : Terminated
First Posted : June 6, 2013
Last Update Posted : September 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Premenstrual Syndrome Mastodynia||Drug: 20mg VAC BNO 1095 FCT Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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
- Maximum severity of cyclic breast pain [ Time Frame: after 3 months treatment under Investigational Medicinal Product (IMP). ]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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870687
|Private Doctor's office - Dr. Hannes Herold|
|Munich, Bavaria, Germany, 80802|
|Study Chair:||Andrzej Witek, MD PhD Prof.|
|Study Chair:||Hannes Herold, Dr. med.|