Clinical Trial: Efficacy and Safety of 20 mg (2 Tablets of 10mg)VAC BNO 1095 FCT on Cyclic Mastodynia and PMS

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary:

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.


Sponsor: Bionorica SE

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Bionorica SE

Dates:
Date Received: May 16, 2013
Date Started: June 2013
Date Completion:
Last Updated: September 12, 2016
Last Verified: September 2016