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

Primary Purpose

Cyclic Mastodynia, Premenstrual Syndrome

Status
Completed
Phase
Phase 3
Locations
Czech Republic
Study Type
Interventional
Intervention
VAC BNO 1095 film coated tablets
Sponsored by
Bionorica SE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cyclic Mastodynia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Females aged 18 to 45 who have signed an Informed Consent Form (ICF) at screening visit S-2 (screening visit -2) at the latest.
  • Subject has a history of cyclic mastodynia and premenstrual syndrome
  • Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2.
  • At screening visit S-2 subject is reporting at least one physical premenstrual syndrome symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list
  • 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 Calendar of Pre-menstrual Experiences (COPE) symptom list

  • In both run-in cycles:

    • Visual analog scale greater or equal 50 mm at least on one of the days of the late luteal phase
    • Cyclic course of the mastodynia, i.e. visual analog scale in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the visual analog scale in the late luteal phase (maximum value of 5 daily recordings)
    • Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must be 20 or more in the late luteal phase (average of daily recordings documented on days -5 to -1)
    • At least one physical premenstrual syndrome symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present
    • Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 10 at day 4 of the menstruation
    • Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 8 in the mid follicular phase (average of daily recordings documented on days 6 to 10)

Note: "Late luteal phase" is defined as days -5 to -1 (5 days prior to the onset of menses) while "mid follicular phase" is defined as days 6 to 10 after the onset of menses.

Exclusion criteria:

  • Pre- Menstrual Dysphoric Disorder

  • Intake of any of the following medications 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
    • Pituitary hormones and their inhibitors
    • Hypothalamic hormones
    • Neuroleptics, antidepressants
    • Serotonin-re-uptake-inhibitors
    • Prolactin-inhibitors or prolactin stimulating preparations
    • Non Steroidal Anti-Inflammatory Drugs (NSAIDs) or any other analgetics including antirheumatics
    • Spironolactone
    • Androgens
    • Gonadotrophin inhibitors
    • Diuretics
    • Danazol
    • Psychotropic agents

Sites / Locations

  • Gynekologicko-porodnická ambulance

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo of VAC BNO 1095

10 mg VAC BNO 1095

20 mg VAC BNO 1095

Arm Description

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

1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of placebo in the evening

1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of VAC BNO 1095 10 mg in the evening

Outcomes

Primary Outcome Measures

Change in maximum severity of cyclic breast pain from baseline to visit 3 evaluated by visual analog scales

Secondary Outcome Measures

Full Information

First Posted
February 23, 2011
Last Updated
July 8, 2013
Sponsor
Bionorica SE
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1. Study Identification

Unique Protocol Identification Number
NCT01309113
Brief Title
Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome
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 Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionorica SE

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyclic Mastodynia, Premenstrual Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo of VAC BNO 1095
Arm Type
Placebo Comparator
Arm Description
1 tablet of placebo in the morning, 1 tablet of placebo in the evening
Arm Title
10 mg VAC BNO 1095
Arm Type
Active Comparator
Arm Description
1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of placebo in the evening
Arm Title
20 mg VAC BNO 1095
Arm Type
Active Comparator
Arm Description
1 tablet of VAC BNO 1095 10 mg in the morning, 1 tablet of VAC BNO 1095 10 mg in the evening
Intervention Type
Drug
Intervention Name(s)
VAC BNO 1095 film coated tablets
Intervention Description
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
Primary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females aged 18 to 45 who have signed an Informed Consent Form (ICF) at screening visit S-2 (screening visit -2) at the latest. Subject has a history of cyclic mastodynia and premenstrual syndrome Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2. At screening visit S-2 subject is reporting at least one physical premenstrual syndrome symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list 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 Calendar of Pre-menstrual Experiences (COPE) symptom list In both run-in cycles: Visual analog scale greater or equal 50 mm at least on one of the days of the late luteal phase Cyclic course of the mastodynia, i.e. visual analog scale in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the visual analog scale in the late luteal phase (maximum value of 5 daily recordings) Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must be 20 or more in the late luteal phase (average of daily recordings documented on days -5 to -1) At least one physical premenstrual syndrome symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 10 at day 4 of the menstruation Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must not exceed 8 in the mid follicular phase (average of daily recordings documented on days 6 to 10) Note: "Late luteal phase" is defined as days -5 to -1 (5 days prior to the onset of menses) while "mid follicular phase" is defined as days 6 to 10 after the onset of menses. Exclusion criteria: Pre- Menstrual Dysphoric Disorder Intake of any of the following medications 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 Pituitary hormones and their inhibitors Hypothalamic hormones Neuroleptics, antidepressants Serotonin-re-uptake-inhibitors Prolactin-inhibitors or prolactin stimulating preparations Non Steroidal Anti-Inflammatory Drugs (NSAIDs) or any other analgetics including antirheumatics Spironolactone Androgens Gonadotrophin inhibitors Diuretics Danazol Psychotropic agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Raus, MD
Organizational Affiliation
PHAMOS Central and Eastern Europe
Official's Role
Study Chair
Facility Information:
Facility Name
Gynekologicko-porodnická ambulance
City
Olomouc
ZIP/Postal Code
771 30
Country
Czech Republic

12. IPD Sharing Statement

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

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