NCT02475564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 5, 2016

Completed
Last Updated

October 14, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

June 11, 2015

Results QC Date

March 24, 2016

Last Update Submit

August 22, 2016

Conditions

Endometriosis

Keywords

resveratrol

Outcome Measures

Primary Outcomes (1)

  • 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.

    42 days

Secondary Outcomes (2)

  • Serum CA125 Levels at 42 Days

    42 days

  • Serum Prolactin Levels at 42 Days

    42 days

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

resveratrol

EXPERIMENTAL

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

Drug: Resveratrol

Interventions

PlaceboDRUG

40mg of starch

Also known as: Starch
placebo
ResveratrolDRUG

40mg of resveratrol (powder)

resveratrol

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Endometriosis diagnosed by laparoscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCPA

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 23528916RESULT

  • 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.

    PMID: 24604232RESULT

  • 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.

    PMID: 23091400RESULT

MeSH Terms

Conditions

Endometriosis

Interventions

StarchResveratrol

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharidesStilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Limitations and Caveats

There were only 42 days of treatment observed, a longer follow-up, for instance 6 months, may impact the results.

Results Point of Contact

Title
Dr. Ricardo Francalacci Savaris
Organization
Hospital de Clínicas de Porto Alegre, RS
rsavaris@hcpa.edu.br
+55 51 33598653

Study Officials

  • Ricardo F Savaris, MD, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 18, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

October 14, 2016

Results First Posted

August 5, 2016

Record last verified: 2016-08

Locations

BR(1)