ClinicalTrials.gov
ClinicalTrials.gov Menu

Resveratrol for Pain Due to Endometriosis (ResvEndo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02475564
Recruitment Status : Completed
First Posted : June 18, 2015
Results First Posted : August 5, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Endometriosis
Interventions: Drug: Placebo
Drug: Resveratrol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between June 18th and November 6th, 2015, 234 women with diagnosis of endometriosis were screened for the study at outpatient clinic of Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

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

Placebo: 40mg of starch

Resveratrol

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

Resveratrol: 40mg of resveratrol (powder)


Participant Flow:   Overall Study
    Placebo   Resveratrol
STARTED   22   22 
COMPLETED   18   21 
NOT COMPLETED   4   1 
Withdrawal by Subject                1                0 
Lost to Follow-up                2                1 
Intense Menstrual bleeding                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Resveratrol

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

Resveratrol: 40mg of resveratrol (powder)

Placebo

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

Placebo: 40mg of starch

Total Total of all reporting groups

Baseline Measures
   Resveratrol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   22   44 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.4  (7.1)   32.4  (7)   33.9  (7.1) 
Gender 
[Units: Participants]
     
Female   22   22   44 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
white   16   15   31 
black   6   7   13 
Region of Enrollment 
[Units: Participants]
     
Brazil   22   22   44 
Baseline pain levels (Visual Analog Scale - VAS) day 1 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.4  (2.6)   5.7  (2)   5.6  (2.3) 
CA-125 
[Units: UI/mL]
Median (Full Range)
 14.1 
 (3.3 to 49.5) 
 18.7 
 (5.7 to 123.6) 
 17.04 
 (3.3 to 123.6) 
Prolactin 
[Units: ng/mL]
Mean (Standard Deviation)
 12.65  (5.9)   14.27  (6.6)   13.13  (6.5) 


  Outcome Measures

1.  Primary:   Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.   [ Time Frame: 42 days ]

2.  Secondary:   Serum CA125 Levels at 42 Days   [ Time Frame: 42 days ]

3.  Secondary:   Serum Prolactin Levels at 42 Days   [ Time Frame: 42 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were only 42 days of treatment observed, a longer follow-up, for instance 6 months, may impact the results.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ricardo Francalacci Savaris
Organization: Hospital de Clínicas de Porto Alegre, RS
phone: +55 51 33598653
e-mail: rsavaris@hcpa.edu.br


Publications of Results:

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02475564     History of Changes
Other Study ID Numbers: 140626
First Submitted: June 11, 2015
First Posted: June 18, 2015
Results First Submitted: March 24, 2016
Results First Posted: August 5, 2016
Last Update Posted: October 14, 2016