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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
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Endometriosis
Interventions Drug: Placebo
Drug: Resveratrol
Enrollment 44
Recruitment Details Between June 18th and November 6th, 2015, 234 women with diagnosis of endometriosis were screened for the study at outpatient clinic of Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil
Pre-assignment Details  
Arm/Group Title Placebo Resveratrol
Hide Arm/Group Description

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)

Placebo: 40mg of starch

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol

Resveratrol: 40mg of resveratrol (powder)

Period Title: Overall Study
Started 22 22
Completed 18 21
Not Completed 4 1
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             2             1
Intense Menstrual bleeding             1             0
Arm/Group Title Resveratrol Placebo Total
Hide Arm/Group Description

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol

Resveratrol: 40mg of resveratrol (powder)

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)

Placebo: 40mg of starch

Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
35.4  (7.1) 32.4  (7) 33.9  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
22
 100.0%
22
 100.0%
44
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
white 16 15 31
black 6 7 13
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 22 participants 22 participants 44 participants
22 22 44
Baseline pain levels (Visual Analog Scale - VAS) day 1   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 22 participants 22 participants 44 participants
5.4  (2.6) 5.7  (2) 5.6  (2.3)
[1]
Measure Description: A 10 cm slide ruler, marked at regular intervals in millimeters, was used for measuring pain intensity on a Visual Analog Scale. The scale had scores ranging continuously from 0 (no pain) to 10 (worst imaginable pain).
CA-125  
Median (Full Range)
Unit of measure:  UI/mL
Number Analyzed 22 participants 22 participants 44 participants
14.1
(3.3 to 49.5)
18.7
(5.7 to 123.6)
17.04
(3.3 to 123.6)
Prolactin  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 22 participants 22 participants 44 participants
12.65  (5.9) 14.27  (6.6) 13.13  (6.5)
1.Primary Outcome
Title Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.
Hide Description 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.
Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis, patients who were lost on follow-up had their last registry on pain values or plasma levels measurements repeated in the following consultations.
Arm/Group Title Resveratrol Placebo
Hide Arm/Group Description:

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol

Resveratrol: 40mg of resveratrol (powder)

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)

Placebo: 40mg of starch

Overall Number of Participants Analyzed 22 22
Median (Full Range)
Unit of Measure: units on a scale
3.2
(0 to 8)
3.9
(0 to 8.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Resveratrol, Placebo
Comments A sample size of at least 21 patients per arm would be necessary to have a 90% chance of detecting, as significant at the 1% level, a difference of 3 points in a scale of 10 points, between both groups as the primary outcome, after 42 days of treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method Mann-Whitney test
Comments [Not Specified]
2.Secondary Outcome
Title Serum CA125 Levels at 42 Days
Hide Description 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).
Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One of subjects from the placebo group decided to leave the study after randomization, thus the n = 21 in the CA125 levels.
Arm/Group Title Resveratrol Placebo
Hide Arm/Group Description:

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol

Resveratrol: 40mg of resveratrol (powder)

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)

Placebo: 40mg of starch

Overall Number of Participants Analyzed 22 21
Median (Full Range)
Unit of Measure: UI/mL
11.7
(4.9 to 29.9)
13.7
(5 to 61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Resveratrol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method Mann-Whitney test
Comments [Not Specified]
3.Secondary Outcome
Title Serum Prolactin Levels at 42 Days
Hide Description Serum levels of prolactin will be measured after 42 days of treatment. Median levels of prolactin were compared between both groups on day 42.
Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
one of the subjects in the placebo group decided to leave the study after randomization, thus n = 21
Arm/Group Title Resveratrol Placebo
Hide Arm/Group Description:

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol

Resveratrol: 40mg of resveratrol (powder)

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)

Placebo: 40mg of starch

Overall Number of Participants Analyzed 22 21
Median (Full Range)
Unit of Measure: ng/mL
12
(4.3 to 32.1)
11.1
(4.2 to 31.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Resveratrol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method Mann-Whitney test
Comments [Not Specified]
Time Frame 42 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Resveratrol
Hide Arm/Group Description

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)

Placebo: 40mg of starch

Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol

Resveratrol: 40mg of resveratrol (powder)

All-Cause Mortality
Placebo Resveratrol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Resveratrol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Resveratrol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/22 (45.45%)      13/22 (59.09%)    
Eye disorders     
Diplopia  1  0/22 (0.00%)  0 1/22 (4.55%)  1
Gastrointestinal disorders     
nausea  1  2/22 (9.09%)  2 1/22 (4.55%)  1
Nervous system disorders     
headache  1 [1]  7/22 (31.82%)  7 6/22 (27.27%)  6
Reproductive system and breast disorders     
Reduced libido  1  0/22 (0.00%)  0 1/22 (4.55%)  1
breast tenderness  1  0/22 (0.00%)  0 1/22 (4.55%)  1
Increased uterine bleeding  1  0/22 (0.00%)  0 1/22 (4.55%)  1
candidiasis  1  0/22 (0.00%)  0 1/22 (4.55%)  1
dispareunia  1  1/22 (4.55%)  1 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hot flushes  1  0/22 (0.00%)  0 1/22 (4.55%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
6 cases of mild headache
There were only 42 days of treatment observed, a longer follow-up, for instance 6 months, may impact the results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Ricardo Francalacci Savaris
Organization: Hospital de Clínicas de Porto Alegre, RS
Phone: +55 51 33598653
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02475564     History of Changes
Other Study ID Numbers: 140626
First Submitted: June 11, 2015
First Posted: June 18, 2015
Results First Submitted: March 24, 2016
Results First Posted: August 5, 2016
Last Update Posted: October 14, 2016