Trial Outcomes & Findings for Resveratrol for Pain Due to Endometriosis (NCT NCT02475564)
NCT ID: NCT02475564
Last Updated: 2016-10-14
Results Overview
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.
COMPLETED
PHASE4
44 participants
42 days
2016-10-14
Participant Flow
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
Participant milestones
| Measure |
Placebo
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
|
Resveratrol
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Placebo
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
|
Resveratrol
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Intense Menstrual bleeding
|
1
|
0
|
Baseline Characteristics
Resveratrol for Pain Due to Endometriosis
Baseline characteristics by cohort
| Measure |
Resveratrol
n=22 Participants
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)
|
Placebo
n=22 Participants
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
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 7 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
black
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Baseline pain levels (Visual Analog Scale - VAS) day 1
|
5.4 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 2 • n=7 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
CA-125
|
14.1 UI/mL
n=5 Participants
|
18.7 UI/mL
n=7 Participants
|
17.04 UI/mL
n=5 Participants
|
|
Prolactin
|
12.65 ng/mL
STANDARD_DEVIATION 5.9 • n=5 Participants
|
14.27 ng/mL
STANDARD_DEVIATION 6.6 • n=7 Participants
|
13.13 ng/mL
STANDARD_DEVIATION 6.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: 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.
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.
Outcome measures
| Measure |
Resveratrol
n=22 Participants
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)
|
Placebo
n=22 Participants
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
|
|---|---|---|
|
Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.
|
3.2 units on a scale
Interval 0.0 to 8.0
|
3.9 units on a scale
Interval 0.0 to 8.9
|
SECONDARY outcome
Timeframe: 42 daysPopulation: One of subjects from the placebo group decided to leave the study after randomization, thus the n = 21 in the CA125 levels.
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).
Outcome measures
| Measure |
Resveratrol
n=22 Participants
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)
|
Placebo
n=21 Participants
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
|
|---|---|---|
|
Serum CA125 Levels at 42 Days
|
11.7 UI/mL
Interval 4.9 to 29.9
|
13.7 UI/mL
Interval 5.0 to 61.0
|
SECONDARY outcome
Timeframe: 42 daysPopulation: one of the subjects in the placebo group decided to leave the study after randomization, thus n = 21
Serum levels of prolactin will be measured after 42 days of treatment. Median levels of prolactin were compared between both groups on day 42.
Outcome measures
| Measure |
Resveratrol
n=22 Participants
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)
|
Placebo
n=21 Participants
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
|
|---|---|---|
|
Serum Prolactin Levels at 42 Days
|
12 ng/mL
Interval 4.3 to 32.1
|
11.1 ng/mL
Interval 4.2 to 31.6
|
Adverse Events
Placebo
Resveratrol
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=22 participants at risk
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
|
Resveratrol
n=22 participants at risk
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Resveratrol: 40mg of resveratrol (powder)
|
|---|---|---|
|
Nervous system disorders
headache
|
31.8%
7/22 • Number of events 7 • 42 days
|
27.3%
6/22 • Number of events 6 • 42 days
|
|
Eye disorders
Diplopia
|
0.00%
0/22 • 42 days
|
4.5%
1/22 • Number of events 1 • 42 days
|
|
Reproductive system and breast disorders
Reduced libido
|
0.00%
0/22 • 42 days
|
4.5%
1/22 • Number of events 1 • 42 days
|
|
Gastrointestinal disorders
nausea
|
9.1%
2/22 • Number of events 2 • 42 days
|
4.5%
1/22 • Number of events 1 • 42 days
|
|
Reproductive system and breast disorders
breast tenderness
|
0.00%
0/22 • 42 days
|
4.5%
1/22 • Number of events 1 • 42 days
|
|
Skin and subcutaneous tissue disorders
Hot flushes
|
0.00%
0/22 • 42 days
|
4.5%
1/22 • Number of events 1 • 42 days
|
|
Reproductive system and breast disorders
Increased uterine bleeding
|
0.00%
0/22 • 42 days
|
4.5%
1/22 • Number of events 1 • 42 days
|
|
Reproductive system and breast disorders
candidiasis
|
0.00%
0/22 • 42 days
|
4.5%
1/22 • Number of events 1 • 42 days
|
|
Reproductive system and breast disorders
dispareunia
|
4.5%
1/22 • Number of events 1 • 42 days
|
0.00%
0/22 • 42 days
|
Additional Information
Dr. Ricardo Francalacci Savaris
Hospital de Clínicas de Porto Alegre, RS
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place