Resveratrol for Pain Due to Endometriosis (ResvEndo)
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|ClinicalTrials.gov Identifier: NCT02475564|
Recruitment Status : Completed
First Posted : June 18, 2015
Results First Posted : August 5, 2016
Last Update Posted : October 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Drug: Placebo Drug: Resveratrol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Use of Resveratrol for Pain in Endometriosis - A Clinical Trial|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Placebo Comparator: placebo
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)
40mg of starch
Other Name: Starch
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
40mg of resveratrol (powder)
- Pain Scores Measured by VAS (Visual Analog Scale) at Day 42. [ Time Frame: 42 days ]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.
- Serum CA125 Levels at 42 Days [ Time Frame: 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).
- Serum Prolactin Levels at 42 Days [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475564
|Porto Alegre, RS, Brazil, 90035-903|
|Principal Investigator:||Ricardo F Savaris, MD, PhD||Hospital de Clínicas de Porto Alegre|