check_circleStudy Completed
Endometriosis and Dysmenorrhea
Bayer Identifier:
18703
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Drug Use Investigation (DUI) of YazFlex for endometriosis-associated pelvic pain and/or dysmenorrhea
Trial purpose
This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.
Key Participants Requirements
Sex
FemaleAge
NaN - N/ATrial summary
Enrollment Goal
715Trial Dates
June 2017 - November 2021Phase
N/ACould I Receive a placebo
NoProducts
EE20/DRSP (BAY86-5300)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Japan |
Primary Outcome
- Number of adverse drug reactions (ADRs)Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA cording system.date_rangeTime Frame:Up to 2 years ( 1 year at the earliest)enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Incidence proportions of YAZ-Flex therapydate_rangeTime Frame:Up to 2 years ( 1 year at the earliest)
- Incidence proportions of extent of bleedingdate_rangeTime Frame:Up to 2 years ( 1 year at the earliest)
- Incidence proportions of treatment suspensionThe duration of suspension is defined as a period of at least 3 consecutive days of treatment suspension.date_rangeTime Frame:Up to 2 years ( 1 year at the earliest)
- Number of days with menstrual painMenstrual pain is continuous menstrual pain or lower abdominal pain that is observed for menstruation or withdrawal blood events and may spread to the back or thigh. Pain may be recognized 2 days before bleeding, and ends by the last day of menstruation or withdrawal.date_rangeTime Frame:Up to 2 years ( 1 year at the earliest)enhanced_encryptionNoSafety Issue:
- Number of date of using analgesicRecord the date of using the analgesic.date_rangeTime Frame:Up to 2 years ( 1 year at the earliest)enhanced_encryptionNoSafety Issue:
- Change in severity of dysmenorrheaThe severity will be evaluated and recorded the following criteria. 1.None 2.Somewhat obstructing work (school or housework) 3. get a problem with one’s work (studies / housework) because the more one wants to lie down 4. Fall asleep for more than 1 day, and cannot do one’s work (school or housework)date_rangeTime Frame:Up to 2 years ( 1 year at the earliest)enhanced_encryptionNoSafety Issue:
- Change in severity of pelvic pain by using Numeric Rating Scale (NRS)The degree of pelvic pain in each menstrual period, menstrual period, sexual intercourse and defecation will be evaluated using NRS score (11 levels from no pain is "0" to highest pain "10" ) in each month.date_rangeTime Frame:Up to 2 years ( 1 year at the earliest)enhanced_encryptionNoSafety Issue:
- Change in quality of Life by using EQ-5D-5L , EIS and/or MDQEndometriosis Impact Scale (EIS) (for disease burden of endometriosis) Menstrual Distress Questionnaire (MDQ) (for disease burden of dysmenorrhea) EQ-5D (for general QOL measurement)date_rangeTime Frame:Up to 2 years ( 1 year at the earliest)
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A