Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
275 participants
OBSERVATIONAL
2012-08-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
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).
Group 2
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Jonesboro, Arkansas, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
New Haven, Connecticut, United States
Decatur, Georgia, United States
Champaign, Illinois, United States
Worcester, Massachusetts, United States
Rochester, Minnesota, United States
Brooklyn, New York, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
San Angelo, Texas, United States
Salt Lake City, Utah, United States
Sandy City, Utah, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Many Locations, , Germany
Countries
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References
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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.
Other Identifiers
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15849
Identifier Type: -
Identifier Source: org_study_id
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