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

NCT01309113 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2013-07-09

No results posted yet for this study

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.

Conditions

  • Cyclic Mastodynia
  • Premenstrual Syndrome

Interventions

DRUG

VAC BNO 1095 film coated tablets

3 dosages: Placebo, 10 mg of VAC BNO 1095 once daily in the morning, 10 mg of VAC BNO 1095 twice daily in the morning and in the evening

Sponsors & Collaborators

  • Bionorica SE

    lead INDUSTRY

Principal Investigators

  • Karel Raus, MD · PHAMOS Central and Eastern Europe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-01-31
Completion
2012-11-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01309113 on ClinicalTrials.gov