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Trial record 41 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

SH T00186 in the Treatment of Primary Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00569244
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE December 5, 2007
First Posted Date  ICMJE December 7, 2007
Last Update Posted Date October 29, 2014
Study Start Date  ICMJE December 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
Number of days with dysmenorrheic pain [ Time Frame: 140 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00569244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
  • Use of rescue medication [ Time Frame: 140 days ]
  • Interference with daily activity [ Time Frame: 140 days ]
  • Number of days: with at least moderate dysmenorrheic pain [ Time Frame: 140 days ]
  • Number of days with pelvic pain [ Time Frame: 140 days ]
  • Number of days with dysmenorrheic pain associated with withdrawal bleeding [ Time Frame: 140 days ]
  • Number of days with dysmenorrheic pain associated with unscheduled bleeding [ Time Frame: 140 days ]
  • Bleeding patterns [ Time Frame: Whole treatment period ]
  • Assessment of treatment [ Time Frame: Whole treatment period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
  • Use of rescue medication [ Time Frame: 140 days ]
  • Interference with daily activity [ Time Frame: 140 days ]
  • Number of days: with at least moderate dysmenorrheic pain; with pelvic pain; associated with withdrawal bleeding; associated with unscheduled bleeding [ Time Frame: 140 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SH T00186 in the Treatment of Primary Dysmenorrhea
Official Title  ICMJE A Multi-center, Open-label, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of an Extended Flexible Regimen of the Combined Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Beta-cyclodextrin Clathrate and 3 mg Drospirenone) Compared to the Conventional Regimen of SH T00186D in the Treatment of Primary Dysmenorrhea
Brief Summary

The investigational drug SH T00186D is an oral contraceptive. The investigational drug used in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone (DRSP).

The aim of the present study is to evaluate efficacy and safety of the investigational drug in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during menstruation). Two different regimens of intake of the same investigational product will be compared.

Patients have to undergo 2 -3 Baseline cycles (depending on whether the patient was an OC user before), during which menstrual pain, bleeding events, and pain killer intake have to be documented. During this observation period, the intake of hormonal contraceptives is not allowed. Other contraceptive methods (condoms with spermicide, pessary with spermicide) have to be used. If the patient is eligible for the study, she will be randomly assigned to one of the two treatment groups. Treatment group A will take the medication according to an extended flexible regimen, i.e., tablet intake will be triggered by bleeding events. Treatment group B will take the study medication in the 24 + 4 days regimen. That means, tablets to be taken on cycle days 1 - 24 contain the hormone combination, whereas tablets 25 - 28 do not contain any active ingredients, i.e., these are so called placebo tablets.

Treatment will last at least 140 days, but can be prolonged in Treatment Group A depending of occurrence of menstrual bleeding. The overall study duration will be 10 months for each patient.

During the whole study period, 5 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breath palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.

Additional examinations can be performed any time, if this becomes necessary for medical reasons.

Patients will be provided with a patient diary to document the intake of study medication, any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic (menstrual) pain and its intensity and its interference with daily activity, and intake of pain medication. The pain medication (ibuprofen) will be provided.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Dysmenorrhea
Intervention  ICMJE
  • Drug: Drug: YAZ flex (SH T00186D)
    Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
  • Drug: YAZ (SH T00186D)
    YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Drug: YAZ flex (SH T00186D)
  • Active Comparator: Arm 2
    Intervention: Drug: YAZ (SH T00186D)
Publications * Strowitzki T, Kirsch B, Elliesen J. Efficacy of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen in women with moderate-to-severe primary dysmenorrhoea: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):94-101. doi: 10.1136/jfprhc-2011-100225.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2009)
223
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2007)
216
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Otherwise healthy female patients with moderate to severe primary dysmenorrhea
  • Prospective self-rated sum pain score of >/= 8 during the 2 baseline cycles
  • Age between 18 and 40 years (inclusive) with smoking habits as follows:

    • between 18 and 30 years of age. daily cigarette consumption not above 10
    • above 30 years of age, no smoking

Exclusion Criteria:

  • Current signs of history of any forms of secondary dysmenorrhea
  • Any concomitant disease of condition that requires any intake of analgesic medication
  • Occurrence of less than six menstrual cycles before Visit 1 following delivery, abortion, or lactation
  • Clinically significant depression
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00569244
Other Study ID Numbers  ICMJE 91587
2006-004899-13 ( EudraCT Number )
310882 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP