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

NCT01870687 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2016-09-14

No results posted yet for this study

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).

Conditions

  • Premenstrual Syndrome
  • Mastodynia

Interventions

DRUG

20mg VAC BNO 1095 FCT

DRUG

Placebo

Sponsors & Collaborators

  • Bionorica SE

    lead INDUSTRY

Principal Investigators

  • Andrzej Witek, MD PhD Prof.

  • Hannes Herold, Dr. med.

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
2013-06-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01870687 on ClinicalTrials.gov