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Resveratrol for Pain Due to Endometriosis

NCT ID: NCT02475564

Last Updated: 2016-10-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

40mg of starch

resveratrol

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

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DRUG

40mg of resveratrol (powder)

Interventions

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Placebo

40mg of starch

Intervention Type DRUG

Resveratrol

40mg of resveratrol (powder)

Intervention Type DRUG

Other Intervention Names

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Starch

Eligibility Criteria

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Inclusion Criteria

* Endometriosis diagnosed by laparoscopy

Exclusion Criteria

* Known allergy to resveratrol
* Use of gonadotropin or danazol in the last month
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo F Savaris, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 23528916 (View on PubMed)

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.

Reference Type RESULT
PMID: 24604232 (View on PubMed)

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.

Reference Type RESULT
PMID: 23091400 (View on PubMed)

Other Identifiers

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140626

Identifier Type: -

Identifier Source: org_study_id

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