check_circleStudy Completed

Primary Dysmenorrhea

Bayer Identifier:

91587

ClinicalTrials.gov Identifier:

NCT00569244

EudraCT Number:

2006-004899-13

EU CT Number:

Not Available
SH T00186 in the Treatment of Primary Dysmenorrhea

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 40 Years

  • - 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

  • - 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

Trial summary

Enrollment Goal
223
Trial Dates
December 2007 - December 2009
Phase
Phase 3
Could I Receive a placebo
No
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Praxis Hr. Dr. R. KuettNürnberg, 90491, Germany
Completed
Praxis Hr. Dr. Karl-Heinz BellingBerlin, 13086, Germany
Completed
Praxis Fr. Dr. B. HeubergerBerlin, 12587, Germany
Completed
Praxis Dr. LarbigFulda, 36037, Germany
Completed
Praxis Fr. Dr. J. TyagiMühlheim, 63165, Germany
Completed
Praxis Fr. Dr. C. BurgkhardtLeipzig, 04299, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
Praxis Hr. Prof. Dr. H.-J. AhrendtMagdeburg, 39126, Germany
Completed
Praxis Fr. A. HewekerBernburg, 06406, Germany
Completed
Praxis Hr. H. ThelenJessen, 06917, Germany
Completed
Frauenarztpraxis Dr. med. Gabriele WeinreichMagdeburg, 39130, Germany
Completed
Frauenarztpraxis Dr. WetzelBlankenburg, 38889, Germany
Completed
Praxis Fr. Dr. A.Mönch-HeringKahla, 07768, Germany
Completed
Praxis Hr. R. WähnertGera, 07545, Germany
Completed
Frauenarztpraxis Hr. Dr. H. LindeckeBerlin, 10247, Germany
Completed
Frauenarztpraxis Fr. Dr. Susanne PlettigBerlin, 10409, Germany
Completed
Praxis Dr. S. El Tobgui-JensenFrankfurt, 60439, Germany
Completed
Praxis Hr. Dr. K. GrevenHannover, 30459, Germany
Completed
Praxis Fr. Dr. J. Schmidt-PichHannover, 30159, Germany
Completed
Praxis Fr. Dr. G. FörsterLeipzig, 04277, Germany
Completed
Praxis Fr. I. GrögerWurzen, 04808, Germany
Completed
Frauenarztpraxis Fr. Dr. Ulrike KriegLeipzig, 04207, Germany
Completed
Praxis Fr. Dr. A. BrauneMagdeburg, 39104, Germany
Completed
Frauenarztpraxis Hr. Dr. Bernd HennigBurg, 39288, Germany
Completed
Frauenarztpraxis Dipl. med. Michael StellmacherBurg, 39288, Germany
Completed
Newcastle General HospitalNewcastle Upon Tyne, NE4 5BE, United Kingdom
Completed
Queen Charlottes & Chelseas HospitalLondon, W12 0HS, United Kingdom
Completed
Avondale SurgeryChesterfield, S40 4TF, United Kingdom

Primary Outcome

  • Number of days with dysmenorrheic pain
    date_rangeTime Frame:
    140 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Use of rescue medication
    date_rangeTime Frame:
    140 days
    enhanced_encryption
    Safety Issue:
    No
  • Interference with daily activity
    date_rangeTime Frame:
    140 days
    enhanced_encryption
    Safety Issue:
    No
  • Number of days: with at least moderate dysmenorrheic pain
    date_rangeTime Frame:
    140 days
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with pelvic pain
    date_rangeTime Frame:
    140 days
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with dysmenorrheic pain associated with withdrawal bleeding
    date_rangeTime Frame:
    140 days
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with dysmenorrheic pain associated with unscheduled bleeding
    date_rangeTime Frame:
    140 days
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding patterns
    date_rangeTime Frame:
    Whole treatment period
    enhanced_encryption
    Safety Issue:
    Yes
  • Assessment of treatment
    date_rangeTime Frame:
    Whole treatment period
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

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