check_circleStudy Completed

Endometriosis and Dysmenorrhea

Bayer Identifier:

18703

ClinicalTrials.gov Identifier:

NCT03126747

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

Female

Age

NaN - N/A
  • - 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.

  • - Patients participating in an investigational program with interventions outside of routine clinical practice.

Trial summary

Enrollment Goal
715
Trial Dates
June 2017 - November 2021
Phase
N/A
Could I Receive a placebo
No
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany 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_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incidence proportions of YAZ-Flex therapy
    date_rangeTime Frame:
    Up to 2 years ( 1 year at the earliest)
  • Incidence proportions of extent of bleeding
    date_rangeTime Frame:
    Up to 2 years ( 1 year at the earliest)
  • Incidence proportions of treatment suspension
    The 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 pain
    Menstrual 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_encryption
    Safety Issue:
    No
  • Number of date of using analgesic
    Record the date of using the analgesic.
    date_rangeTime Frame:
    Up to 2 years ( 1 year at the earliest)
    enhanced_encryption
    Safety Issue:
    No
  • Change in severity of dysmenorrhea
    The 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_encryption
    Safety Issue:
    No
  • 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_encryption
    Safety Issue:
    No
  • Change in quality of Life by using EQ-5D-5L , EIS and/or MDQ
    Endometriosis 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

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
N/A

Additional Information

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