Resveratrol for Pain Due to Endometriosis (ResvEndo)

August 22, 2016 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • HCPA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Endometriosis diagnosed by laparoscopy

Exclusion Criteria:

  • Known allergy to resveratrol
  • Use of gonadotropin or danazol in the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
42 days
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.
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Ricardo F Savaris, MD, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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