Resveratrol for Pain Due to Endometriosis

Endometriosis Clinical Trial

— ResvEndo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02475564
• Other study ID #: 140626
• Status: Recruiting
• Phase: Phase 4
• First received: June 11, 2015
• Last updated: June 17, 2015
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Daniel M da Silva, Pharm.
• Phone: 55 51 33597542
• Email: danielmsilva[@]hcpa.edu.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Endometriosis diagnosed by laparoscopy

Exclusion Criteria:

• Known allergy to resveratrol

• Use of gonadotropin or danazol in the last month

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Placebo
40mg of starch
• Resveratrol
40mg of resveratrol (powder)

Locations

Country	Name	City	State
Brazil	HCPA	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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: 10.1177/193371911452 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain scores measured by VAS at 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	42 days	No
Secondary	Change from baseline in serum CA125 levels at 42 days	Serum levels of CA125 will be measured at the beginning and at the end of the study	42 days	No
Secondary	Change from baseline in serum Prolactin levels at 42 days	Serum levels of prolactin will be measured at the beginning and at the end of the study	42 days	No