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Pain Associated With Endometriosis

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: NCT00758953
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : March 6, 2012
Sponsor:
Information provided by (Responsible Party):
Lumara Health, Inc.

Tracking Information
First Submitted Date  ICMJE September 23, 2008
First Posted Date  ICMJE September 25, 2008
Last Update Posted Date March 6, 2012
Study Start Date  ICMJE February 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
Pain associated with endometriosis [ Time Frame: 3 months of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
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 Pain Associated With Endometriosis
Official Title  ICMJE Not Provided
Brief Summary This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: Danazol Once Weekly
    semi-solid
  • Drug: Danazol Twice Weekly
    semi-solid
  • Drug: Placebo Once Weekly
    semi-solid
  • Drug: Placebo Twice Weekly
    semi-solid
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Danazol Once Weekly
  • Experimental: 2
    Intervention: Drug: Danazol Twice Weekly
  • Placebo Comparator: 3
    Intervention: Drug: Placebo Once Weekly
  • Placebo Comparator: 4
    Intervention: Drug: Placebo Twice Weekly
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 24, 2008)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Menstruating female 18-50 years of age,
  • Regular cycle length of 21 to 35 days with menstrual bleeding that typically lasts no more than 7 days,
  • Has pain associated with endometriosis,
  • Has a documented history consistent with endometriosis,

Exclusion Criteria:

  • Is pregnant or lactating,
  • Has a history of or has active thrombosis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00758953
Other Study ID Numbers  ICMJE DZ2-201-601-725036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lumara Health, Inc.
Study Sponsor  ICMJE Lumara Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jim Joffrion Lumara Health, Inc.
PRS Account Lumara Health, Inc.
Verification Date March 2012

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