MRI-Based Prediction of Dienogest Response in Endometriosis
ConditionEndometriosis, Ovarian
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19-45
SponsorChungnam National University Sejong Hospital
About this trial
The goal of this prospective observational study is to learn whether magnetic resonance imaging (MRI) findings can help predict treatment response to dienogest in women with endometriosis. Endometriosis is a common gynecologic condition that can cause chronic pelvic pain and negatively affect quality of life. Although dienogest is widely used as a standard medical treatment, individual responses to treatment vary.
The main questions this study aims to answer are:
* Whether baseline MRI characteristics of endometriotic lesions are associated with improvement in pelvic pain after dienogest treatment. * Whether MRI findings can help identify patients who are more likely to benefit from dienogest therapy.
Participants diagnosed with endometriosis who are prescribed dienogest as part of their routine clinical care will be enrolled. This study does not assign any investigational intervention. Participants will undergo standard clinical follow-up, including pelvic pain assessment using visual analog scale (VAS) scores, quality of life questionnaires, and routine MRI examinations. Clinical and imaging data will be collected prospectively and analyzed to explore imaging predictors of treatment response.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants who have received a full explanation of the study and have provided written informed consent
Women aged 19 to 45 years who have been diagnosed with endometriosis by a board-certified obstetrician-gynecologist
Patients who have not received any hormonal treatment within the previous 3 months
Patients who have never been treated with dienogest
Disqualifiers
Patients with a history of treatment with dienogest
Patients with contraindications to dienogest
Patients who are unable to undergo magnetic resonance imaging (MRI) (e.g., presence of metallic implants)
Patients who are currently pregnant or planning pregnancy within the next 6 months
Trial population
This study will include women aged 19 to 45 years who have been clinically diagnosed with endometriosis by an obstetrician-gynecologist. Eligible participants are those who have not received hormonal treatment within the previous 3 months and have never been treated with dienogest. All participants must provide written informed consent prior to enrollment. Patients with contraindications to dienogest, inability to undergo MRI, current or planned pregnancy within 6 months, or poor general medical condition will be excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Change in pelvic pain severity assessed by visual analog scale.
Pelvic pain severity will be measured using the Visual Analog Scale , ranging from 0 to 10, where higher scores indicate more severe pelvic pain. The primary outcome is the change in Visual Analog Scale score from baseline to 12 months after initiation of dienogest treatment.
Time frame
Baseline to 12 months after initiation of dienogest treatmentSecondary outcomes
1
Change in quality of life assessed by the Endometriosis Health Profile-30 (EHP-30)
Quality of life will be assessed using the Endometriosis Health Profile-30 (EHP-30), a validated patient-reported outcome questionnaire specific to endometriosis. The Endometriosis Health Profile(EHP-30) core questionnaire scores range from 0 to 100, with higher scores indicating worse health-related quality of life. The secondary outcome measure is the change in Endometriosis Health Profile(EHP-30) total score from baseline to follow-up during dienogest treatment.
Time frame
Baseline to 12 months2
Change From Baseline in MRI Characteristics of Endometriotic Lesions
The secondary outcome is the change from baseline in the size of endometriotic lesions measured on magnetic resonance imaging (MRI). Lesion size will be defined as the maximum diameter of the target lesion measured in millimeters on MRI at baseline and after 12 months of dienogest treatment. A reduction in lesion size indicates improvement.
Time frame
Baseline to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov