NCT03126747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
715

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 29, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

4 years

First QC Date

April 20, 2017

Last Update Submit

November 13, 2022

Conditions

Endometriosis and Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • Number of adverse drug reactions (ADRs)

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

    Up to 2 years ( 1 year at the earliest)

Secondary Outcomes (8)

  • Incidence proportions of YAZ-Flex therapy

    Up to 2 years ( 1 year at the earliest)

  • Incidence proportions of extent of bleeding

    Up to 2 years ( 1 year at the earliest)

  • Incidence proportions of treatment suspension

    Up to 2 years ( 1 year at the earliest)

  • Number of days with menstrual pain

    Up to 2 years ( 1 year at the earliest)

  • Number of date of using analgesic

    Up to 2 years ( 1 year at the earliest)

  • +3 more secondary outcomes

Study Arms (1)

BAY86-5300_YAZ-Flex

Patients with endometriosis-associated pelvic pain or dysmenorrhea

Drug: BAY86-5300_YAZ-Flex

Interventions

BAY86-5300_YAZ-FlexDRUG

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

BAY86-5300_YAZ-Flex

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Endometriosis-associated pelvic pain and/or Dysmenorrhea

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many locations

Multiple Locations, Japan

Location

Related Publications (1)

  • 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.

    PMID: 36053449DERIVED

Related Links

MeSH Terms

Conditions

EndometriosisDysmenorrhea

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 24, 2017

Study Start

June 29, 2017

Primary Completion

June 17, 2021

Study Completion

November 17, 2021

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Locations

JP(1)