Clinical trial NCT03126747: Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea
Official title: Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis and Dysmenorrhea
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 715
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Endometriosis-associated pelvic pain and/or Dysmenorrhea

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse drug reactions (ADRs)
timeFrame: Up to 2 years ( 1 year at the earliest)
Secondary outcomes:
measure: Incidence proportions of YAZ-Flex therapy
timeFrame: Up to 2 years ( 1 year at the earliest)
measure: Incidence proportions of extent of bleeding
timeFrame: Up to 2 years ( 1 year at the earliest)
measure: Incidence proportions of treatment suspension
timeFrame: Up to 2 years ( 1 year at the earliest)
measure: Number of days with menstrual pain
timeFrame: Up to 2 years ( 1 year at the earliest)
measure: Number of date of using analgesic
timeFrame: Up to 2 years ( 1 year at the earliest)
measure: Change in severity of dysmenorrhea
timeFrame: Up to 2 years ( 1 year at the earliest)
measure: Change in severity of pelvic pain by using Numeric Rating Scale (NRS)
timeFrame: Up to 2 years ( 1 year at the earliest)
measure: Change in quality of Life by using EQ-5D-5L , EIS and/or MDQ
timeFrame: Up to 2 years ( 1 year at the earliest)
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Yoshino O, Suzukamo Y, Yoshihara K, Takahashi N. Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study. Adv Ther. 2022 Nov;39(11):5087-5104. doi: 10.1007/s12325-022-02301-3. Epub 2022 Sep 2.