check_circleStudy Completed

Primary Dysmenorrhea

Bayer Identifier:

91781

ClinicalTrials.gov Identifier:

NCT00909857

EudraCT Number:

2008-005625-11

EU CT Number:

Not Available
Effect on primary dysmenorrhea

Trial purpose

To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.

Key Participants Requirements

Sex

Female

Age

14 - 50 Years
  • - Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
    - Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
    - Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
    - Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
    - Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.
  • - Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
    - Obesity: body mass index (BMI) > 32 kg/m2
    - Hypersensitivity to any of the study drug ingredients
    - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
    - Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding
    - Abuse of alcohol, drugs, or medicines (e.g. laxatives)
    - Other contraceptive methods:
     -- Sterilization
     -- Oral, vaginal or transdermal hormonal contraception during treatment
     -- Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1
    - Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
    - Major surgery scheduled for the study period

Trial summary

Enrollment Goal
507
Trial Dates
April 2009 - November 2010
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum FreiburgFreiburg, 79106, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
Evangelisches Krankenhaus Köln Weyertal gGmbHKöln, 50931, Germany
Completed
Mount Vernon Clinical Research, LLCSandy Springs, 30328, United States
Completed
Rosemark Women Care SpecialistIdaho Falls, 83404, United States
Completed
Clinical Trials Research Services, LLCPittsburgh, 15206, United States
Completed
AGA Clinical TrialsHialeah, 33012, United States
Completed
University of Wisconsin - La CrosseLa Crosse, 54691, United States
Completed
Lyndhurst Clinical ResearchWinston-Salem, 27103, United States
Completed
Azienda Policlinico Umberto IRoma, 00161, Italy
Completed
A.O.U. di Modena PoliclinicoModena, 41124, Italy
Completed
A.O.U. di BolognaBologna, 40138, Italy
Completed
AUSL Brindisi - PugliaFrancavilla Fontana, 72021, Italy
Completed
St. Michael's Hospital Health CentreToronto, M5C 2T2, Canada
Completed
Praxis Hr. Dr. H. GerlachEssen, 45127, Germany
Completed
Praxis Hr. Dr. K. PetersHamburg, 22159, Germany
Completed
Praxis Hr. Prof. Dr. H.-J. AhrendtMagdeburg, 39126, Germany
Completed
Praxis Fr. A. HewekerBernburg, 06406, Germany
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Office of Dr. Alfred Moffett, MDLeesburg, 34748, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
Genova Clinical Research, Inc.Tucson, 85741, United States
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
A.O.U. Santa Maria Misericordia UDUdine, 33100, Italy
Completed
A.O. OIRM - S.AnnaTorino, 10126, Italy
Completed
A.O. Spedali CiviliBrescia, 25123, Italy
Completed
A.O. Fatebenefratelli e OftalmicoMilano, 20121, Italy
Completed
A.O.U. di PerugiaPerugia, 06156, Italy
Completed
Glover Medical ClinicLangley, V3A 4H9, Canada
Terminated
Regina Medical CentreRegina, S4P 3X1, Canada
Completed
Consultorio del Dr. CastiglioneSantiago, Chile
Completed
Clínica Las CondesSantiago de Chile, Chile
Completed
Instituto Chileno de Medicina ReproductivaSantiago de Chile, Chile
Terminated
Hospital Clínico Universidad de ChileSantiago, Chile
Completed
Philippine General HospitalMetro Manila, 1000, Philippines
Terminated
Hospice and Palliative CenerCebu City, Philippines
Completed
Clinique Médicale des CampusSte-Foy, G1V 4X7, Canada
Completed
Kells Medical Research Group, Inc.Pointe-Claire, H9R 4S3, Canada
Completed
Universidad de Concepcion Hospital Las HiguerasTalcahuano, Chile
Completed
Consultorio MirafloresTemuco, 4790711, Chile
Terminated
Manila Doctors HospitalMetro Manila, Philippines
Completed
Chong Hua HospitalCebu, Philippines
Completed
St. Luke’s Medical CenterQuezon City, Philippines
Completed
Medical TowerDavao, Philippines

Primary Outcome

  • Change between baseline evaluation period and treatment evaluation period in the number of days with dysmenorrheric pain
    date_rangeTime Frame:
    baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change between baseline evaluation period and treatment evaluation period in the sum of score points of dysmenorrheric pain
    date_rangeTime Frame:
    baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    enhanced_encryption
    Safety Issue:
    No
  • Change between baseline evaluation period and treatment evaluation period in number of days with pelvic pain independent of occurrence of vaginal bleeding
    date_rangeTime Frame:
    baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    enhanced_encryption
    Safety Issue:
    No
  • Change between baseline evaluation period and treatment evaluation period in number of days with pelvic pain during unscheduled bleeding
    date_rangeTime Frame:
    baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    enhanced_encryption
    Safety Issue:
    No
  • Change between baseline evaluation period and treatment evaluation period in rescue medication use (only bleeding episode used including the two days before the episode)
    date_rangeTime Frame:
    baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    enhanced_encryption
    Safety Issue:
    No
  • Change between baseline evaluation period and treatment evaluation period in rescue medication use (entire evaluation period used)
    date_rangeTime Frame:
    baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with interference of dysmenorrheic pain with work/school and social or other activity (only bleeding episode used including the two days before)
    date_rangeTime Frame:
    baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with interference of dysmenorrheic pain with work/school and social or other activity (entire evaluation period used)
    date_rangeTime Frame:
    baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants satisfied with study treatment
    date_rangeTime Frame:
    From cycle 1 to cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with bleeding or spotting
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of episodes with bleeding or spotting
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of bleeding or spotting episodes
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of bleeding or spotting episodes
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest bleeding or spotting episodes
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of days with spotting-only
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Number of episodes with spotting-only
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Mean length of spotting only episodes
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of spotting only episodes
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Difference in duration between longest and shortest spotting only episode
    date_rangeTime Frame:
    From day 1 to day 90
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with withdrawal bleeding at cycle 1
    date_rangeTime Frame:
    At cycle 1 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with withdrawal bleeding at cycle 3
    date_rangeTime Frame:
    At cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Length of withdrawal bleeding episodes at cycle 1
    date_rangeTime Frame:
    At cycle 1 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Length of withdrawal bleeding episodes at cycle 3
    date_rangeTime Frame:
    At cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum intensity of withdrawal bleeding episodes at cycle 1
    date_rangeTime Frame:
    At cycle 1 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum intensity of withdrawal bleeding episodes at cycle 3
    date_rangeTime Frame:
    At cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Onset of withdrawal bleeding episodes at cycle 1
    date_rangeTime Frame:
    At cycle 1 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Onset of withdrawal bleeding episodes at cycle 3
    date_rangeTime Frame:
    At cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with intracyclic bleeding at cycle 1
    date_rangeTime Frame:
    At cycle 1 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with intracyclic bleeding at cycle 3
    date_rangeTime Frame:
    At cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding episodes at cycle 1
    date_rangeTime Frame:
    At cycle 1 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding episodes at cycle 3
    date_rangeTime Frame:
    At cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of intracyclic bleeding episodes at cycle 1
    date_rangeTime Frame:
    At cycle 1 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum length of intracyclic bleeding episodes at cycle 3
    date_rangeTime Frame:
    At cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding days at cycle 1
    date_rangeTime Frame:
    At cycle 1 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Number of intracyclic bleeding days at cycle 3
    date_rangeTime Frame:
    At cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with maximum intensity of intracyclic bleeding episodes at cycle 1
    date_rangeTime Frame:
    At cycle 1 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with maximum intensity of intracyclic bleeding episodes at cycle 3
    date_rangeTime Frame:
    At cycle 3 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants missing time from work due to dysmenorrheic pain at screening
    date_rangeTime Frame:
    At screening (28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants missing time from work due to dysmenorrheic pain at baseline cycle
    date_rangeTime Frame:
    At Baseline (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants missing time from work due to dysmenorrheic pain at cycle 2
    date_rangeTime Frame:
    At cycle 2 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants missing time from work to dysmenorrheic pain at final examination
    date_rangeTime Frame:
    At final examination (28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Own costs of physiotherapy per treatment converted to U.S. dollars as measured by Resource Use Questionaire
    date_rangeTime Frame:
    At screening (average over 3 months before screening)
    enhanced_encryption
    Safety Issue:
    No
  • Own costs of pain medication per treatment converted to U.S. dollars as measured by Resource Use Questionaire
    date_rangeTime Frame:
    At screening (average over 3 months before screening)
    enhanced_encryption
    Safety Issue:
    No
  • Own costs of vitamins per treatment converted to U.S. dollars as measured by resources Use Questionaire
    date_rangeTime Frame:
    At screening (average over 3 months before screening)
    enhanced_encryption
    Safety Issue:
    No
  • Own costs of massages per treatment converted to U.S. dollars as measured by Resource Use Questionaire
    date_rangeTime Frame:
    At screening (average over 3 months before screening)
    enhanced_encryption
    Safety Issue:
    No
  • Own costs of accupuncture per treatment converted to U.S. dollars as measured by Resource of Use Questionaire
    date_rangeTime Frame:
    At screening (average over 3 months before screening)
    enhanced_encryption
    Safety Issue:
    No
  • Own costs of medical counseling per treatment converted to U.S. dollars as measured by Resource Use Questionaire
    date_rangeTime Frame:
    At screening (average over 3 months before screening)
    enhanced_encryption
    Safety Issue:
    No
  • Own costs of alternative medicine per treatment converted to U.S. dollars as measured by Recource Use Questionaire
    date_rangeTime Frame:
    At screening (average over 3 months before screening)
    enhanced_encryption
    Safety Issue:
    No
  • Own costs of herbs/teas per treatment converted to U.S. dollars as measured by Resource Use Questionaire
    date_rangeTime Frame:
    At screening (average over 3 months before screening)
    enhanced_encryption
    Safety Issue:
    No
  • Other own costs per treatment converted to U.S. dollars measured by Resource Use Questionaire
    date_rangeTime Frame:
    At screening (average over 3 months before screening)
    enhanced_encryption
    Safety Issue:
    No
  • Participants with improvement in the investigator's assessment in the Clinical Global Impression
    date_rangeTime Frame:
    At cycle 2 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Participants with improvement in participants' assessment in the Clinical Global Impression
    date_rangeTime Frame:
    At cycle 2 (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Physical functioning as measured by General health and well.being questionaire SF-36 at baseline cycle
    date_rangeTime Frame:
    At baseline cycle (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Physical functioning as measured by general health and well-being questionaire SF-36 at final examination
    date_rangeTime Frame:
    at final examiniation (28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Social functioning as measured by General health and well-being questionaire SF-36 at baseline cycle
    date_rangeTime Frame:
    At baseline cycle (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Social functioning as measured by General health and well-being questionaire SF-36 at final examination
    date_rangeTime Frame:
    At final examination (28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Mental health as measured by General health and well-being questionaire SF-36 at baseline cycle
    date_rangeTime Frame:
    At baseline cycle (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mental health as measured by General health and well-being questionaire SF-36 at final examination
    date_rangeTime Frame:
    At final examination (28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Vitality as measured by General health and well-being questionaire SF-36 at baseline cycle
    date_rangeTime Frame:
    At baseline cycle (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Vitality as measured by General health and well-being questionaire SF-36 at final examination
    date_rangeTime Frame:
    At final examination (28 days)
    enhanced_encryption
    Safety Issue:
    No
  • General health as measured by General health and well-being questionaire SF-36 at baseline cycle
    date_rangeTime Frame:
    At baseline cycle (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • General health as measured by general health and well-being questionaire SF-36 at final examination
    date_rangeTime Frame:
    At final examination (28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Role physical as measured by General health and well-being questionaire SF-36 at baseline cycle
    date_rangeTime Frame:
    At baseline cycle (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Role physical as measured by General health and well-being questionaire SF-36 at final examination
    date_rangeTime Frame:
    At final examination (28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Role emotional as measured by general health and well-being questionaire SF-36 at baseline cycle
    date_rangeTime Frame:
    At baseline cycle (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Role emotional as mesured by General health and well-being questionaire SF-36 at final examination
    date_rangeTime Frame:
    At final examination (28 days)
    enhanced_encryption
    Safety Issue:
    No
  • Bodily pain as measured by General health well-being questionaire SF-36 at baseline cycle
    date_rangeTime Frame:
    At baseline cycle (28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Bodily pain as measured by General health and well-being questionaire SF-36 at final examination
    date_rangeTime Frame:
    At final examination (28 days)
    enhanced_encryption
    Safety Issue:
    No

Trial design

A multi-center, double-blind, double-dummy, randomized, controlled, parallel-group study to assess efficacy and safety of SH T00658ID compared to SH D593B in the treatment of primary dysmenorrhea
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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