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To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea

Primary Purpose

Dysmenorrhea

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
EE20/DRSP(YAZ,BAY86-5300)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suffering from dysmenorrhea for at least the previous 3 months prior to Visit 1 with a minimum visual analogue scale (VAS) score of 30 mm with regard to pain during the menstrual period of the screening period
  • Good general health (except for findings related to dysmenorrhea) as proven by medical history
  • Patients aged 18 years or older at the time of obtaining informed consent; smokers must not be older than 35 years at the time point of informed consent
  • Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains (HPV 16, HPV18).
  • Women of childbearing potential must agree that adequate contraception will be used when they are sexually active. This applies from signing of the informed consent form until 2 weeks after the last study drug administration.

Exclusion Criteria:

  • Pregnancy (confirmed or suspected) or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
  • Patients who wish to become pregnant during the course of the study
  • Body Mass Index (BMI) > 32 kg/m2
  • Hypersensitivity to any ingredient of the study drug
  • Laboratory values outside inclusion range before randomization
  • Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    BAY86-5300

    Placebo

    Arm Description

    Patients suffering from dysmenorrhea, treated with Yaz

    Patients suffering from dysmenorrhea,treated with placebo

    Outcomes

    Primary Outcome Measures

    Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6
    The patient marks the individual pain impression on a visual analogue scale in the range 0 (no pain) to 100mm (worst pain ever experienced)

    Secondary Outcome Measures

    Number of participants with adverse events as measure of safety and tolerability
    Number of days with dysmenorrhea
    The occurrence of dysmenorrhea will be recorded in the patient diary
    Change in dysmenorrhea score
    It is the sum of two four-stage sub-scales which assess the extent to which dysmenorrhea interferes with daily life & the extent to which pain medication is used.
    Changes from baseline to each menstrual period of total number of taken supportive analgesic medication
    Standard Analgesic tablets are provided to participants
    Changes from baseline to each menstrual period of days without supportive analgesic medication.
    Clinical Global Impression(CGI)
    The CGI is the measure of global improvement index from the opinion of the investigator and subject to document changes in the health status during treatment
    Self administered SF-36 questionnaire
    The 36-items Short Form Health Survey (SF-36) (version 2.0) is a set of generic, coherent,and easily administered quality-of-life measures.
    Changes from baseline to each menstrual period of severity of lumbago
    The patient classifies the severity on a mild, moderate, severe scale
    Changes from baseline to each menstrual period of severity of headache
    The patient classifies the severity on a mild, moderate, severe scale
    Changes from baseline to each menstrual period of severity of nausea/vomiting
    The patient classifies the severity on a mild, moderate, severe scale

    Full Information

    First Posted
    November 23, 2015
    Last Updated
    February 15, 2016
    Sponsor
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02617537
    Brief Title
    To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea
    Official Title
    A Multinational, Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study to Investigate the Efficacy and Safety of the Oral Hormonal Contraceptive BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) Over 16 Weeks for the Treatment of Women With Dysmenorrhea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bayer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysmenorrhea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BAY86-5300
    Arm Type
    Experimental
    Arm Description
    Patients suffering from dysmenorrhea, treated with Yaz
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients suffering from dysmenorrhea,treated with placebo
    Intervention Type
    Drug
    Intervention Name(s)
    EE20/DRSP(YAZ,BAY86-5300)
    Intervention Description
    0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo tablets for 28 days per 28-day intake cycle
    Primary Outcome Measure Information:
    Title
    Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6
    Description
    The patient marks the individual pain impression on a visual analogue scale in the range 0 (no pain) to 100mm (worst pain ever experienced)
    Time Frame
    Baseline to week 17
    Secondary Outcome Measure Information:
    Title
    Number of participants with adverse events as measure of safety and tolerability
    Time Frame
    Up to 16 weeks
    Title
    Number of days with dysmenorrhea
    Description
    The occurrence of dysmenorrhea will be recorded in the patient diary
    Time Frame
    Up to 16 weeks
    Title
    Change in dysmenorrhea score
    Description
    It is the sum of two four-stage sub-scales which assess the extent to which dysmenorrhea interferes with daily life & the extent to which pain medication is used.
    Time Frame
    Baseline to week 16
    Title
    Changes from baseline to each menstrual period of total number of taken supportive analgesic medication
    Description
    Standard Analgesic tablets are provided to participants
    Time Frame
    Baseline to week 16
    Title
    Changes from baseline to each menstrual period of days without supportive analgesic medication.
    Time Frame
    Baseline to week 16
    Title
    Clinical Global Impression(CGI)
    Description
    The CGI is the measure of global improvement index from the opinion of the investigator and subject to document changes in the health status during treatment
    Time Frame
    At week 16
    Title
    Self administered SF-36 questionnaire
    Description
    The 36-items Short Form Health Survey (SF-36) (version 2.0) is a set of generic, coherent,and easily administered quality-of-life measures.
    Time Frame
    At baseline and week 17
    Title
    Changes from baseline to each menstrual period of severity of lumbago
    Description
    The patient classifies the severity on a mild, moderate, severe scale
    Time Frame
    Up to 16 weeks
    Title
    Changes from baseline to each menstrual period of severity of headache
    Description
    The patient classifies the severity on a mild, moderate, severe scale
    Time Frame
    Up to 16 weeks
    Title
    Changes from baseline to each menstrual period of severity of nausea/vomiting
    Description
    The patient classifies the severity on a mild, moderate, severe scale
    Time Frame
    Up to 16 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients suffering from dysmenorrhea for at least the previous 3 months prior to Visit 1 with a minimum visual analogue scale (VAS) score of 30 mm with regard to pain during the menstrual period of the screening period Good general health (except for findings related to dysmenorrhea) as proven by medical history Patients aged 18 years or older at the time of obtaining informed consent; smokers must not be older than 35 years at the time point of informed consent Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains (HPV 16, HPV18). Women of childbearing potential must agree that adequate contraception will be used when they are sexually active. This applies from signing of the informed consent form until 2 weeks after the last study drug administration. Exclusion Criteria: Pregnancy (confirmed or suspected) or lactation (less than three months since delivery, abortion, or lactation before start of treatment) Patients who wish to become pregnant during the course of the study Body Mass Index (BMI) > 32 kg/m2 Hypersensitivity to any ingredient of the study drug Laboratory values outside inclusion range before randomization Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bayer Study Director
    Organizational Affiliation
    Bayer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea

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