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SH T00186 in the Treatment of Primary Dysmenorrhea

This study is ongoing, but not recruiting participants.

Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00569244
  Purpose

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.


Condition Intervention Phase
Primary Dysmenorrhea
Drug: YAZ flex (SH T00186D)
Drug: YAZ (SH T00186D)
Phase III

MedlinePlus related topics:   Birth Control    Menstruation    Pelvic Pain   

ChemIDplus related topics:   Ethinyl estradiol    1,2-Dihydrospirorenone    Betadex   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of days with dysmenorrheic pain [ Time Frame: 140 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of rescue medication [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Interference with daily activity [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Number of days: with at least moderate dysmenorrheic pain; [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Number of days with pelvic pain [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Number of days with dysmenorrheic pain associated with withdrawal bleeding [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Number of days with dysmenorrheic pain associated with unscheduled bleeding [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Bleeding patterns [ Time Frame: Whole treatment period ] [ Designated as safety issue: Yes ]
  • Assessment of treatment [ Time Frame: Whole treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:   216
Study Start Date:   December 2007
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm 1: Experimental Drug: YAZ flex (SH T00186D)
Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
Arm 2: Active Comparator Drug: YAZ (SH T00186D)
YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))

  Eligibility
Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569244

Locations
Germany, Baden-Württemberg / 275
      Heidelberg, Baden-Württemberg / 275, Germany, 69112
Germany, Bayern / 280
      Nürnberg, Bayern / 280, Germany, 90491
Germany, Berlin / 285
      Berlin, Berlin / 285, Germany, 13086
      Berlin, Berlin / 285, Germany, 12587
      Berlin, Berlin / 285, Germany, 10247
      Berlin, Berlin / 285, Germany, 10409
Germany, Hessen / 307
      Frankfurt, Hessen / 307, Germany, 60439
      Frankfurt, Hessen / 307, Germany, 60322
      Fulda, Hessen / 307, Germany, 36037
      Mühlheim, Hessen / 307, Germany, 63165
Germany, Niedersachsen / 291
      Hannover, Niedersachsen / 291, Germany, 30459
      Hannover, Niedersachsen / 291, Germany, 30159
Germany, Rheinland-Pfalz / 381
      Speyer, Rheinland-Pfalz / 381, Germany, 67346
Germany, Sachsen / 313
      Leipzig, Sachsen / 313, Germany, 04299
      Leipzig, Sachsen / 313, Germany, 04277
      Dresden, Sachsen / 313, Germany, 01067
      Wurzen, Sachsen / 313, Germany, 04808
      Großpösna, Sachsen / 313, Germany, 04463
      Leipzig, Sachsen / 313, Germany, 04207
Germany, Sachsen-Anhalt / 311
      Magdeburg, Sachsen-Anhalt / 311, Germany, 39126
      Magdeburg, Sachsen-Anhalt / 311, Germany, 39104
      Burg, Sachsen-Anhalt / 311, Germany, 39288
      Bernburg, Sachsen-Anhalt / 311, Germany, 06406
      Jessen, Sachsen-Anhalt / 311, Germany, 06917
      Magdeburg, Sachsen-Anhalt / 311, Germany, 39130
      Blankenburg, Sachsen-Anhalt / 311, Germany, 38889
Germany, Thüringen / 310
      Kahla, Thüringen / 310, Germany, 07768
      Gera, Thüringen / 310, Germany, 07545
United Kingdom
      London, United Kingdom, W12 0HS

Sponsors and Collaborators
Bayer

Investigators
Study Director:     Bayer Study Director     Bayer    
  More Information


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Responsible Party:   Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:   91587, EudraCT No.: 2006-004899-13, 310882
First Received:   December 5, 2007
Last Updated:   September 24, 2008
ClinicalTrials.gov Identifier:   NCT00569244
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Primary Dysmenorrhea  
Menstrual Pain  
Oral Contraception  

Study placed in the following topic categories:
Signs and Symptoms
Pelvic Pain
Menstruation Disturbances
Dysmenorrhea
Drospirenone
Ethinyl Estradiol
Pain

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008




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