Trial Condition(s):
Endometriosis and Dysmenorrhea
Drug Use Investigation (DUI) of YazFlex for endometriosis-associated pelvic pain and/or dysmenorrhea
Bayer Identifier:
18703
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
Inclusion Criteria
- Patients with endometriosis-associated pelvic pain and/or dysmenorrhea. - Patients for whom the decision to initiate treatment with YazFlex is made as per physician’s clinical practice.
Exclusion Criteria
- Patients participating in an investigational program with interventions outside of routine clinical practice.
Trial Summary
Enrollment Goal
715
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Many locations Many locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Drug Use Investigation (DUI) of YazFlex for endometriosis-associated pelvic pain and/or dysmenorrhea
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
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.Timeframe: Up to 2 years ( 1 year at the earliest)
Secondary Outcome
- Incidence proportions of YAZ-Flex therapyTimeframe: Up to 2 years ( 1 year at the earliest)
- Incidence proportions of extent of bleedingTimeframe: 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.Timeframe: 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.Timeframe: Up to 2 years ( 1 year at the earliest)
- Number of date of using analgesicRecord the date of using the analgesic.Timeframe: Up to 2 years ( 1 year at the earliest)
- 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)Timeframe: Up to 2 years ( 1 year at the earliest)
- 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.Timeframe: Up to 2 years ( 1 year at the earliest)
- 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)Timeframe: Up to 2 years ( 1 year at the earliest)
Additional Information
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