Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation Study for Endometriosis PRO (VALEPRO)

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: NCT01643122
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date July 4, 2012
First Posted Date July 17, 2012
Last Update Posted Date October 13, 2014
Study Start Date August 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2012)
Endometriosis symptoms rated by the Endometriosis Symptom Diary [ Time Frame: Up to 24 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation Study for Endometriosis PRO
Official Title Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis
Brief Summary Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable, valid and able to detect changes over time in approximately 250 patients with mild, moderate or severe endometriosis confirmed by laparoscopy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with endometriosis confirmed by laparoscopy
Condition Endometriosis
Intervention
  • Other: No drug
    Patients with expected stable endometriosis management status (EMS), i.e. patients who have not planned a change in endometriosis treatment or a therapeutic surgical procedure in the next 12 weeks and have had no change in endometriosis treatment or therapeutic surgical procedure in the previous 4 weeks.lease specify as free-text; for drugs include daily dose, dosage form dosage frequency and duration (if appl. and possible for the OS/NIS).
  • Other: No drug
    Patients with expected change in endometriosis management status (EMS), i.e. patients who have planned a change in endometriosis treatment or a therapeutic surgical procedure during the next 12 weeks or have undergone a change in endometriosis treatment or a therapeutic surgical procedure in the previous 4 weeks.
Study Groups/Cohorts
  • Group 1
    Intervention: Other: No drug
  • Group 2
    Intervention: Other: No drug
Publications * Seitz C, Lanius V, Lippert S, Gerlinger C, Haberland C, Oehmke F, Tinneberg HR. Patterns of missing data in the use of the endometriosis symptom diary. BMC Womens Health. 2018 Jun 8;18(1):88. doi: 10.1186/s12905-018-0578-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 14, 2013)
275
Original Estimated Enrollment
 (submitted: July 16, 2012)
250
Actual Study Completion Date September 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women with endometriosis confirmed by laparoscopy or laparotomy within five years before the baseline visit
  • Good general health (except for findings related to endometriosis) as proven by medical history
  • Patient has experienced endometriosis symptoms (i.e. pain) in the past 4 weeks, as assessed by a numerical rating scale (NRS)

Exclusion Criteria:

  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Undiagnosed abnormal genital bleeding
  • Abuse of alcohol, drugs, or medicine (e.g., laxatives)
  • Simultaneous participation in another clinical trial. 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, except therapeutic surgical procedure for endometriosis
  • Close affiliation with the study site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of study site)
  • Inability to cooperate with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site
  • Previous enrollment to this study
  • Regular use of pain medication due to other underlying diseases
  • Known pregnancy
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01643122
Other Study ID Numbers 15849
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2014