Resveratrol for Pain Due to Endometriosis

Study Overview
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Brief Summary
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This study aims to verify whether the use of 40 mg of resveratrol per day associated with monophasic contraceptive pill (levonorgestrel 0.15mg/ethinyl estradiol 0.03mg) reduces pelvic pain at the end of 2 months of treatment, compared to the use of the pill with placebo.

Detailed Description
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Endometriosis is a disease that affects 176 million women around the world, and it is present in about 60% of adolescent women with chronic pelvic pain and dysmenorrhea. Some researchers have investigated the antiproliferative effect of resveratrol in endometriosis using animal models and humans. The reduction in the size and activity of the endometriotic implants has been observed with the use of resveratrol. The reduction of pain in patients with endometriosis is an important aspect of the quality of life. The use of a medication with few side effects and the lack of clinical quality trials justify this study, which aims to verify whether the use of 40 mg of resveratrol per day associated with monophasic contraceptive pill reduces pelvic pain at the end of 2 months of treatment, compared to the use of the pill with placebo. This study will be randomized, prospective, double blind with two arms of 22 patients; the CONSORT parameters will be followed. The degree of pain by visual analog scale, prolactin levels (ng / mL) and the carcinoembryonic antigen levels (CA125) (IU / L) will be measured at the begging and at the end of trial. These parameters will be the outcomes.

Official Title
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The Use of Resveratrol for Pain in Endometriosis - A Clinical Trial

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Placebo
* Drug: Resveratrol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endometriosis diagnosed by laparoscopy Exclusion Criteria: Known allergy to resveratrol Use of gonadotropin or danazol in the last month

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch) | Drug: Placebo<br>* 40mg of starch<br>* Other names: Starch;|
| Experimental: resveratrol<br>Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol | Drug: Resveratrol<br>* 40mg of resveratrol (powder)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores Measured by VAS (Visual Analog Scale) at Day 42. | Pain will be measured by VAS (visual analog scale) as baseline and at the end of the study, considering the last 7 days. VAS was used to measuring pain intensity, ranging continuously from 0 (no pain) to 10 (worst imaginable pain). The main outcome compared median pain levels between both arms on day 42. | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum CA125 Levels at 42 Days | Serum levels of CA125 will be measured after 42 days of treatment in UI/mL. Median levels of CA125 were compared between both groups on day 42, and to baseline values (day 1). | 42 days | 
| Serum Prolactin Levels at 42 Days | Serum levels of prolactin will be measured after 42 days of treatment. Median levels of prolactin were compared between both groups on day 42. | 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resveratrol