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Trial record 59 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT02617537
Recruitment Status : Withdrawn
First Posted : December 1, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: EE20/DRSP(YAZ,BAY86-5300) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Experimental: BAY86-5300
Patients suffering from dysmenorrhea, treated with Yaz
Drug: EE20/DRSP(YAZ,BAY86-5300)
0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle

Placebo Comparator: Placebo
Patients suffering from dysmenorrhea,treated with placebo
Drug: Placebo
Matching placebo tablets for 28 days per 28-day intake cycle




Primary Outcome Measures :
  1. Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6 [ Time Frame: Baseline to week 17 ]
    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 :
  1. Number of participants with adverse events as measure of safety and tolerability [ Time Frame: Up to 16 weeks ]
  2. Number of days with dysmenorrhea [ Time Frame: Up to 16 weeks ]
    The occurrence of dysmenorrhea will be recorded in the patient diary

  3. Change in dysmenorrhea score [ Time Frame: Baseline to week 16 ]
    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.

  4. Changes from baseline to each menstrual period of total number of taken supportive analgesic medication [ Time Frame: Baseline to week 16 ]
    Standard Analgesic tablets are provided to participants

  5. Changes from baseline to each menstrual period of days without supportive analgesic medication. [ Time Frame: Baseline to week 16 ]
  6. Clinical Global Impression(CGI) [ Time Frame: At week 16 ]
    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

  7. Self administered SF-36 questionnaire [ Time Frame: At baseline and week 17 ]
    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.

  8. Changes from baseline to each menstrual period of severity of lumbago [ Time Frame: Up to 16 weeks ]
    The patient classifies the severity on a mild, moderate, severe scale

  9. Changes from baseline to each menstrual period of severity of headache [ Time Frame: Up to 16 weeks ]
    The patient classifies the severity on a mild, moderate, severe scale

  10. Changes from baseline to each menstrual period of severity of nausea/vomiting [ Time Frame: Up to 16 weeks ]
    The patient classifies the severity on a mild, moderate, severe scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617537


Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02617537     History of Changes
Other Study ID Numbers: 16419
2015-003924-29 ( EudraCT Number )
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms