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Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07393958

Experimental Study of Quality of Life in Patients With Endometriosis and Pelvic Pain Treated With Doliral Dietary Supplementation Versus Placebo

Led by Arafarma Group, S.A. · Updated on 2026-03-02

60

Participants Needed

1

Research Sites

6 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether the food supplement Doliral can improve quality of life and reduce pelvic pain in women diagnosed with endometriosis. The study compares Doliral to a placebo over a period of 12 weeks, focusing on women of reproductive age with specific stages of endometriosis and pelvic pain. The trial is designed to assess changes in quality of life and pain intensity, with patients grouped based on hormonal therapy use. Participants are randomly assigned to one of two groups one receiving Doliral and the other a placebo. Each participant takes one buccal tablet daily from the baseline visit to the final visit, spanning 12 weeks. The study includes six visits one selection visit, a baseline visit, and four follow-up visits to monitor progress and collect data. During the study, patients complete a daily symptom diary and record their use of pain and anti-inflammatory medications. At each visit, pain intensity is assessed using the Visual Analog Scale VAS for different types of endometriosis pain. Several quality of life questionnaires are also completed. Researchers will monitor changes in pain, quality of life, medication use, and the frequency of clinically relevant episodes, ensuring close follow-up over the study period.

CONDITIONS

Brief Title

Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women of reproductive age with diagnosed endometriosis stage I, II, or III, according to the American Society for Reproductive Medicine classification
  • Diagnosis of endometriosis confirmed by laparoscopy or, if not available, by MRI and/or ultrasound
  • Presence of pelvic pain with a Visual Analog Scale (VAS) score greater than 4 during the last three months
  • No indication for surgical intervention at the time of inclusion
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Use of analgesic or anti-inflammatory treatment other than ibuprofen up to 600 mg/day or naproxen up to 500 mg/day
  • Surgery within the year before inclusion related to the study pathology
  • Starting or stopping hormone therapy within three months before inclusion
  • Known allergy or hypersensitivity to Doliral
  • Pregnant or breastfeeding
  • On sick leave for more than 1 year, with no intention to return to work, or undergoing disability or permanent incapacity assessment

Research Team

T

Tamara Rodríguez Araya, Dr

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