Clinical Trial: Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-blind Comparison of VAC BNO 1095 Film Coated Tablets With Placebo to Identify Dose Dependent Effects in Patients Suffering From Cyclic Mastodynia and Premenstrual S

Brief Summary:

Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180 patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are expected to complete the study per protocol.

Study objectives:

Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for treatment of cyclic mastodynia and premenstrual syndrome.

To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic mastodynia.

Dose regimen:

Group 1: VAC BNO 1095 1x10 mg:

1 tablet of verum in the morning, 1 placebo tablet in the evening

Group 2: VAC BNO 1095 2x10 mg:

1 tablet of verum in the morning, 1 tablet of verum in the evening

Group 3: Placebo:

1 tablet placebo in the morning, 1 tablet placebo in the evening

The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening 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.

Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of menstruation number n, with exception of the first screening visit which can be performed at any time prior to the firs

Detailed Summary:
Sponsor: Bionorica SE

Current Primary Outcome: Change in maximum severity of cyclic breast pain from baseline to visit 3 evaluated by visual analog scales [ Time Frame: Daily from the first day of first menstruation to the last study visit (22 weeks) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bionorica SE

Dates:
Date Received: February 23, 2011
Date Started: March 2011
Date Completion:
Last Updated: July 8, 2013
Last Verified: July 2013