Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is an observational, multicenter, prospective, single arm study to evaluate the efficacy of dydrogesterone in endometriosis-related pain (EAP).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dydrogesterone group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dydrogesterone | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
This study is planned to enroll 250 patients who have endometrosis-related pain (ERP) (dysmenorrhea, Chronic pelvic pain (CPP), dyspereunia, and other ERP) and are planned to be treated with dydrogesterone per the physician's decision.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tony Piha, MD MBA | Contact | +41 614870907 | tony.piha@abbott.com |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | From baseline to Cycle 3 and Cycle 6 ("Cycle" refers to menstrual cycle, 1 cycle is 28 days on average) |
| 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" | 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. | 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. | 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. | 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: 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. |
| D000091662 | Genital Diseases |
| D011083 |
| Polycyclic Compounds |