Resveratrol for Pain Due to Endometriosis (ResvEndo)
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
Resveratrol
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring resveratrol
Eligibility Criteria
Inclusion Criteria:
- Endometriosis diagnosed by laparoscopy
Exclusion Criteria:
- Known allergy to resveratrol
- Use of gonadotropin or danazol in the last month
Sites / Locations
- HCPA
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
resveratrol
Arm Description
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT02475564
First Posted
June 11, 2015
Last Updated
August 22, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02475564
Brief Title
Resveratrol for Pain Due to Endometriosis
Acronym
ResvEndo
Official Title
The Use of Resveratrol for Pain in Endometriosis - A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
resveratrol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)
Arm Title
resveratrol
Arm Type
Experimental
Arm Description
Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Starch
Intervention Description
40mg of starch
Intervention Type
Drug
Intervention Name(s)
Resveratrol
Intervention Description
40mg of resveratrol (powder)
Primary Outcome Measure Information:
Title
Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.
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
Secondary Outcome Measure Information:
Title
Serum CA125 Levels at 42 Days
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
Title
Serum Prolactin Levels at 42 Days
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Endometriosis diagnosed by laparoscopy
Exclusion Criteria:
Known allergy to resveratrol
Use of gonadotropin or danazol in the last month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo F Savaris, MD, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
HCPA
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23528916
Citation
Johnson NP, Hummelshoj L; World Endometriosis Society Montpellier Consortium. Consensus on current management of endometriosis. Hum Reprod. 2013 Jun;28(6):1552-68. doi: 10.1093/humrep/det050. Epub 2013 Mar 25.
Results Reference
result
PubMed Identifier
24604232
Citation
Amaya SC, Savaris RF, Filipovic CJ, Wise JD, Hestermann E, Young SL, Lessey BA. Resveratrol and endometrium: a closer look at an active ingredient of red wine using in vivo and in vitro models. Reprod Sci. 2014 Nov;21(11):1362-9. doi: 10.1177/1933719114525271. Epub 2014 Mar 6.
Results Reference
result
PubMed Identifier
23091400
Citation
Maia H Jr, Haddad C, Pinheiro N, Casoy J. Advantages of the association of resveratrol with oral contraceptives for management of endometriosis-related pain. Int J Womens Health. 2012;4:543-9. doi: 10.2147/IJWH.S36825. Epub 2012 Oct 10.
Results Reference
result
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Resveratrol for Pain Due to Endometriosis
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