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Completed

NCT Number: NCT03126747

Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea

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.

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Key information

Conditions

Endometriosis and Dysmenorrhea Dysmenorrhea Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Many locations

Multiple Locations, Japan

About this study

It is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with YazFlex in endometriosis or dysmenorrhea indication.

A total of 600 patients (300 for endometriosis and 300 for dysmenorrhea) is planned to be enrolled in 2 years.

The treatment should be performed in Japan based on the product label. The patients will be observed for up to 2 years (1 year at the earliest) during their YazFlex treatment.

The outcome variables for the primary objective are treatment emergent adverse events (TEAEs) and adverse drug reactions (ADRs). The outcome variables for the secondary objective include newly developed haemorrhagic ovarian cyst, genital bleeding, severity of dysmenorrhea, pelvic pain and compliance status in the new flexible regimen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAY86-5300_YAZ-Flex

Drug

Patients with endometriosis-associated pelvic pain and/or dysmenorrhea are enrolled solely after the physician's decision of YazFlex treatment in routine clinical practice.

Primary outcomes

  1. Number of adverse drug reactions (ADRs)

    Time frame: Up to 2 years ( 1 year at the earliest)

    Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA cording system.

Secondary outcomes

  1. Incidence proportions of YAZ-Flex therapy

    Time frame: Up to 2 years ( 1 year at the earliest)

  2. Incidence proportions of extent of bleeding

    Time frame: Up to 2 years ( 1 year at the earliest)

  3. Incidence proportions of treatment suspension

    Time frame: Up to 2 years ( 1 year at the earliest)

    The duration of suspension is defined as a period of at least 3 consecutive days of treatment suspension.

  4. Number of days with menstrual pain

    Time frame: Up to 2 years ( 1 year at the earliest)

    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.

  5. Number of date of using analgesic

    Time frame: Up to 2 years ( 1 year at the earliest)

    Record the date of using the analgesic.

  6. Change in severity of dysmenorrhea

    Time frame: Up to 2 years ( 1 year at the earliest)

    The severity will be evaluated and recorded the following criteria.

    • None
    • Somewhat obstructing work (school or housework)
    • get a problem with one's work (studies / housework) because the more one wants to lie down
    • Fall asleep for more than 1 day, and cannot do one's work (school or housework)

  7. Change in severity of pelvic pain by using Numeric Rating Scale (NRS)

    Time frame: Up to 2 years ( 1 year at the earliest)

    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.

  8. Change in quality of Life by using EQ-5D-5L , EIS and/or MDQ

    Time frame: Up to 2 years ( 1 year at the earliest)

    Endometriosis Impact Scale (EIS) (for disease burden of endometriosis) Menstrual Distress Questionnaire (MDQ) (for disease burden of dysmenorrhea) EQ-5D (for general QOL measurement)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2017
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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