Clinical trial NCT00909857: Effect on Primary Dysmenorrhea
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea
Oral Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-29
Enrollment: 507
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
timeFrame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
Secondary outcomes:
measure: Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain
timeFrame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
measure: Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding
timeFrame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
measure: Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding
timeFrame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
measure: Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)
timeFrame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
measure: Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)
timeFrame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
measure: Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)
timeFrame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
measure: Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)
timeFrame: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
measure: Percentage of Participants Satisfied With Study Treatment
timeFrame: From cycle 1 to cycle 3 (28 days per cycle)
measure: Number of Days With Bleeding or Spotting
timeFrame: From day 1 to day 90
measure: Number of Episodes With Bleeding or Spotting
timeFrame: From day 1 to day 90
measure: Mean Length of Bleeding or Spotting Episodes
timeFrame: From day 1 to day 90
measure: Maximum Length of Bleeding or Spotting Episodes
timeFrame: From day 1 to day 90
measure: Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode
timeFrame: From day 1 to day 90
measure: Number of Days With Spotting-only
timeFrame: From day 1 to day 90
measure: Number of Episodes With Spotting-only
timeFrame: From day 1 to day 90
measure: Mean Length of Spotting Only Episodes
timeFrame: From day 1 to day 90
measure: Maximum Length of Spotting Only Episodes
timeFrame: From day 1 to day 90
measure: Difference in Duration Between Longest and Shortest Spotting Only Episode
timeFrame: From day 1 to day 90
measure: Percentage of Participants With Withdrawal Bleeding at Cycle 1
timeFrame: At cycle 1 (28 days per cycle)
measure: Percentage of Participants With Withdrawal Bleeding at Cycle 3
timeFrame: At cycle 3 (28 days per cycle)
measure: Length of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: At cycle 1 (28 days per cycle)
measure: Length of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: At cycle 3 (28 days per cycle)
measure: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: At cycle 1 (28 days per cycle)
measure: Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: At cycle 3 (28 days per cycle)
measure: Onset of Withdrawal Bleeding Episodes at Cycle 1
timeFrame: At cycle 1 (28 days per cycle)
measure: Onset of Withdrawal Bleeding Episodes at Cycle 3
timeFrame: At cycle 3 (28 days per cycle)
measure: Percentage of Participants With Intracyclic Bleeding at Cycle 1
timeFrame: At cycle 1 (28 days per cycle)
measure: Percentage of Participants With Intracyclic Bleeding at Cycle 3
timeFrame: At cycle 3 (28 days per cycle)
measure: Number of Intracyclic Bleeding Episodes at Cycle 1
timeFrame: At cycle 1 (28 days per cycle)
measure: Number of Intracyclic Bleeding Episodes at Cycle 3
timeFrame: At cycle 3 (28 days per cycle)
measure: Maximum Length of Intracyclic Bleeding Episodes at Cycle 1
timeFrame: At cycle 1 (28 days per cycle)
measure: Maximum Length of Intracyclic Bleeding Episodes at Cycle 3
timeFrame: At cycle 3 (28 days per cycle)
measure: Number of Intracyclic Bleeding Days at Cycle 1
timeFrame: At cycle 1 (28 days per cycle)
measure: Number of Intracyclic Bleeding Days at Cycle 3
timeFrame: At cycle 3 (28 days per cycle)
measure: Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1
timeFrame: At cycle 1 (28 days per cycle)
measure: Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3
timeFrame: At cycle 3 (28 days per cycle)
measure: Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening
timeFrame: At screening (28 days)
measure: Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle
timeFrame: At Baseline (28 days per cycle)
measure: Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2
timeFrame: At cycle 2 (28 days per cycle)
measure: Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination
timeFrame: At final examination (28 days)
measure: Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
timeFrame: At screening (average over 3 months before screening)
measure: Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
timeFrame: At screening (average over 3 months before screening)
measure: Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
timeFrame: At screening (average over 3 months before screening)
measure: Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
timeFrame: At screening (average over 3 months before screening)
measure: Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
timeFrame: At screening (average over 3 months before screening)
measure: Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
timeFrame: At screening (average over 3 months before screening)
measure: Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
timeFrame: At screening (average over 3 months before screening)
measure: Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
timeFrame: At screening (average over 3 months before screening)
measure: Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire
timeFrame: At screening (average over 3 months before screening)
measure: Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression
timeFrame: At cycle 2 (28 days per cycle)
measure: Participants With Improvement in Participants' Assessment in the Clinical Global Impression
timeFrame: At cycle 2 (28 days per cycle)
measure: Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
timeFrame: At baseline cycle (28 days per cycle)
measure: Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
timeFrame: at final examination (28 days)
measure: Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
timeFrame: At baseline cycle (28 days per cycle)
measure: Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
timeFrame: At final examination (28 days)
measure: Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
timeFrame: At baseline cycle (28 days per cycle)
measure: Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
timeFrame: At final examination (28 days)
measure: Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
timeFrame: At baseline cycle (28 days per cycle)
measure: Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
timeFrame: At final examination (28 days)
measure: General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
timeFrame: At baseline cycle (28 days per cycle)
measure: General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
timeFrame: At final examination (28 days)
measure: Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
timeFrame: At baseline cycle (28 days per cycle)
measure: Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
timeFrame: At final examination (28 days)
measure: Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
timeFrame: At baseline cycle (28 days per cycle)
measure: Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
timeFrame: At final examination (28 days)
measure: Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle
timeFrame: At baseline cycle (28 days per cycle)
measure: Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination
timeFrame: At final examination (28 days)
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Hialeah
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Sandy Springs
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Winston-Salem
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: La Crosse
country: United States
state: Wisconsin
city: Langley
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Pointe-Claire
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Santiago de Chile
country: Chile
city: Santiago
country: Chile
city: Talcahuano
country: Chile
city: Temuco
country: Chile
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Bernburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Hamburg
country: Germany
city: Francavilla Fontana
country: Italy
state: Brindisi
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Perugia
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
city: Cebu City
country: Philippines
city: Cebu
country: Philippines
city: Davao
country: Philippines
city: Metro Manila
country: Philippines
city: Metro Manila
country: Philippines
city: Quezon City
country: Philippines
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Petraglia F, Parke S, Serrani M, Mellinger U, Romer T. Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea. Int J Gynaecol Obstet. 2014 Jun;125(3):270-4. doi: 10.1016/j.ijgo.2013.11.017. Epub 2014 Mar 11.