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Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat 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: NCT00212342
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 8, 2010
Sponsor:
Information provided by:
Nobelpharma

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date September 8, 2010
Study Start Date  ICMJE December 2004
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2007)
patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2007)
  • changes in the VAS of dysmenorrhea.
  • changes in the VRS of non-menstrual pain.
  • changes in the VAS of non-menstrual pain.
  • changes in the clinical evaluation of pelvic induration.
  • changes in the size of ovarian endometrioma.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
Official Title  ICMJE Phase 3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.
Brief Summary The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dysmenorrhea
Intervention  ICMJE
  • Drug: Norethisterone,Ethinylestradiol
  • Drug: Sugar pill
Study Arms  ICMJE
  • Experimental: Norethisterone,Ethinylestradiol
    Intervention: Drug: Norethisterone,Ethinylestradiol
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Sugar pill
Publications * Not Provided

*   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: September 6, 2010)
100
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • dysmenorrhea associated with endometriosis

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00212342
Other Study ID Numbers  ICMJE IKH-01-4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Nobelpharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Naoki Terakawa, M.D.,Ph.D. Tottori University,Tottori,Japan
PRS Account Nobelpharma
Verification Date September 2010

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