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| Name | Class |
|---|---|
| Fundació Clínic per la Recerca Biomedica | UNKNOWN |
| Dr. Christian Dursteler | UNKNOWN |
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This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Participants are treated with the investigational medical product |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabinoid treatment | Drug | Participants are treated with cannabinoid derivates with a dose between 1 to 12 puffs, each puffs contains 2,7 mg of delta-9-tetrahidrocannabinol and 2,5 mg of cannabidiol. |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure threshold in hypogastrium that induces pain | Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa | day 30 after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure threshold in dermatomes that induces pain | Umbral of pain versus mechanical stimulation in dermatomes L2 anterior, L2 posterior, and T1 of the dominant upper extremity. | baseline, day 15, day 30 and day 45 |
| Temperature threshold in dermatomes that induces pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Dursteler, MD | Contact | +34.93.227.54.00 | dursteler@clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Barcelona | Catalonia | 08036 | Spain |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Umbral sensation versus thermal stimulus (cold heat) in anterior central L2 dermatomes, posterior central L2, and T1 of the dominant upper extremity. Measured in ºC. |
| baseline, day 15, day 30 and day 45 |
| Intensity of the general pain | Intensity of the general pain associated with endometriosis measured by a visual analogue scale (0-10) | baseline, day 15, day 30 and day 45 |
| Anxiety and depression combined scale | Anxiety and depression measured with the Scale of Anxiety and Hospital Depression Scale (HADS). | baseline, day 15, day 30 and day 45 |
| Quality of Life | Quality of Life measured through the EQ-5D-5L questionnaire. | baseline, day 15, day 30 and day 45 |
| Central sensitivity | Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire. | baseline, day 15, day 30 and day 45 |
| Cognitive disorder measured by a list of words | Cognitive disorder measured by a list of words (immediate memory and retention) and digits (attentional capacity) of the Wechsler Memory Scale (WMS-III). | baseline, day 15, day 30 and day 45 |
| about sleep quality | Visual analogue scale 0-10 about sleep quality | baseline, day 15, day 30 and day 45 |
| D000091662 | Genital Diseases |