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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY86-5300_YAZ-Flex | Patients with endometriosis-associated pelvic pain or dysmenorrhea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
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Inclusion Criteria:
Exclusion Criteria:
- Patients participating in an investigational program with interventions outside of routine clinical practice.
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Endometriosis-associated pelvic pain and/or Dysmenorrhea
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36053449 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Incidence proportions of treatment suspension |
The duration of suspension is defined as a period of at least 3 consecutive days of treatment suspension. |
| 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. | Up to 2 years ( 1 year at the earliest) |
| Number of date of using analgesic | Record the date of using the analgesic. | Up to 2 years ( 1 year at the earliest) |
| Change in severity of dysmenorrhea | The severity will be evaluated and recorded the following criteria.
| 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. | Up to 2 years ( 1 year at the earliest) |
| 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) | Up to 2 years ( 1 year at the earliest) |
| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |