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Clinical Trials/EUCTR2012-005042-37-DE
EUCTR2012-005042-37-DE
Active, not recruiting
Not Applicable

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 from cyclic mastodynia and PMS - Efficacy and safety of 20 mg (2 tablets of 10 mg) VAC BNO 1095 FCT on cyclic mastodynia and PMS

Bionorica SE0 sites280 target enrollmentFebruary 7, 2013
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ConditionsCyclic mastodynia and PMSTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cyclic mastodynia and PMS
Sponsor
Bionorica SE
Enrollment
280
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 7, 2013
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Females aged 18 to 45 who have signed an ICF at screening visit S\-2 at the latest
  • •2\. Subject has a history of cyclic mastodynia and PMS at visit S\-2
  • •3\. Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S\-2 and during run in phase
  • •4\. At screening visit S\-2 subject is reporting at least one physical PMS symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the COPE symptom list
  • •5\. At screening visit S\-2 subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the COPE symptom list
  • •6\. In both run\-in cycles:
  • •6A. VAS \= 50 at least on one of the days of the late luteal phase
  • •6B. Cyclic course of the mastodynia, i.e. VAS in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the VAS in the late luteal phase (maximum value of 5 daily recordings)
  • •6C. PMS sum score resulting from COPE must be 20\.0 or more in the late luteal phase (average of daily recordings documented on days \-5 to \-1\)
  • •6D. At least one physical PMS symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present

Exclusion Criteria

  • •1\. Hypersensitivity to the active substance or to any of the excipients of the IMP at visit S\-2
  • •2\. Proof of PMDD at visit S\-2 according to DSM\-IV criteria as defined by APA \[American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders , 4th ed. Text Revision. Washington, DC: American Psychiatric Association, 2000] based on the findings as follows:
  • •A total of at least 5 premenstrual symptoms with at least one severe mood symptom must be present. The instrument used for retrospective assessment will be a questionnaire according to DSM\-IV criteria.
  • •In addition, the symptoms
  • •must have a history of 1\-year duration
  • •must seriously interfere with work, relationships or social activities
  • •must not be an exacerbation of another disease
  • •3\. Intake of any of the following medications (including herbal or homeopathic drugs) before treatment start (visit S\-2 up to visit V0\) and within 6 months prior to visit S\-2:
  • •any treatment for mastodynia or premenstrual complaints
  • •sexual hormones, combinations and inhibitors

Outcomes

Primary Outcomes

Not specified

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