The study is an observational, multicenter, prospective, single arm study to evaluate the efficacy of dydrogesterone in endometriosis-related pain (EAP).
Study Type
OBSERVATIONAL
Enrollment
250
The duration of treatment with dydrogesterone is determined by the physician before inclusion in the study and will last for 6 menstrual cycles ("Cycle" used in the protocol refers to menstrual cycle. 1 cycle is 28 days on average)
Changes in visual analogue scale (VAS) score of dysmenorrhea, Chronic Pelvic Pain (CPP), dyspareunia, and other Endometriosis related Pain (ERP) after dydrogesterone treatment from baseline to Cycle 6.
The VAS consists of a 100-mm line with the end points no pain and worst pain, which "absence of pain" corresponds to the value of "0" and unbearable pain corresponding to the value of "100" . Patients will be asked to point the average pain intensity throughout the last menstrual cycle.
Time frame: From baseline to Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)
Changes in visual analogue scale (VAS) score of dysmenorrhea, Chronic Pelvic Pain(CPP), dyspareunia, and other Endometriosis related Pain (ERP) after dydrogesterone treatment from baseline to Cycle 3.
The visual analogue scale (VAS) consists of a 100-mm line with the end points no pain and worst pain, which "absence of pain" corresponds to the value of "0" and unbearable pain corresponding to the value of "100". Patients will be asked to point the average pain intensity throughout the last menstrual cycle.
Time frame: From baseline to Cycle 3 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)
Changes in Endometriosis Health Profile Questionnaire-30 (EHP-30) after dydrogesterone treatment from baseline to Cycle 3 and Cycle 6.
For the EHP-30, scale scores are standardized on a range from 0 to 100. The higher scores indicate worse health status.
Time frame: From baseline to Cycle 3 and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)
Changes in score of pain domain of Endometriosis Health Profile Questionnaire (EHP-30) from baseline to Cycle 3 and Cycle 6.
For the pain domain of EHP-30, scale scores are standardised on a range from 0 to 100. The higher scores indicate more severe pain.
Time frame: From baseline to Cycle 3 and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)
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Changes in sexual well-being after dydrogesterone treatment by 5-points Likert scale from baseline to Cycle 3 and Cycle 6.
A patient-reported sexual wellbeing by 5-points Likert scale proposes patients to rate themselves on a 5-point scale as being "very satisfied, satisfied, ordinarily, rather not satisfied, not satisfied"
Time frame: From baseline to Cycle 3 and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)
Changes in menstrual cycle duration from baseline to Cycle 3 and Cycle 6.
Time frame: From baseline to Cycle 3 and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)
The number of days per menstrual cycle when analgesics are taken at baseline, Cycle 3, and Cycle 6.
Time frame: At baseline, Cycle 3, and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)
The proportion of participants with amenorrhea, infrequent bleeding, frequent bleeding, irregular bleeding, prolonged bleeding upon treatment with dydrogesterone at baseline, Cycle 3, and Cycle 6.
Time frame: At baseline, Cycle 3, and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average)
The absolute number and percentage of adverse drug reactions (ADRs) / other pharmacovigilance-relevant information (OPRI) reported with dydrogesterone treatment.
Time frame: Time Frame: From informed consent to last contact (refers to cycle 6 visit, where "Cycle" refers to menstrual cycle, 1 cycle is 28 days on average) or 5 half-lives (75 hours from the last dose), whichever is longer.