Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
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 first run-in cycle. Subsequently the time between the first study visit
and the onset of the first run-in cycle menses T shall be added to the overall study
duration.
In case that the next menstruation does not commence as expected, the patient should contact
her investigator immediately in order to schedule a new appointment, approximately on the
actual day 3 of the menses.