Trial · NCT03126747
Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea
NCT03126747, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea. Trials, record NCT03126747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03126747
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea
- NCT number
- NCT03126747
- Status
- Completed
- Enrollment
- 715 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Endometriosis and Dysmenorrhea
- Interventions
- BAY86-5300_YAZ-Flex
- First posted
- 2017-04-24
- Last updated
- 2022-11-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of adverse drug reactions (ADRs) | 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 | Incidence proportions of YAZ-Flex therapy | Up to 2 years ( 1 year at the earliest) | |
| Secondary | Incidence proportions of extent of bleeding | Up to 2 years ( 1 year at the earliest) | |
| Secondary | Incidence proportions of treatment suspension | 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. |
| Secondary | Number of days with menstrual pain | 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. |
| Secondary | Number of date of using analgesic | Up to 2 years ( 1 year at the earliest) | Record the date of using the analgesic. |
| Secondary | Change in severity of dysmenorrhea | Up to 2 years ( 1 year at the earliest) | 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) |
| Secondary | Change in severity of pelvic pain by using Numeric Rating Scale (NRS) | 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. |
| Secondary | Change in quality of Life by using EQ-5D-5L , EIS and/or MDQ | 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) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36053449 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03126747
GET https://conductscience.org/api/trials/v1/NCT03126747/registered