Evaluation of endometriosis-associated pain Urological and Genital Diseases
Conditions
Interventions
In this randomized, double-blind, placebo-controlled clinical trial, 40 women who were taking a daily oral dose of dienogest (2 mg) were randomly assigned using aleatoric randomisation with a SAS (Sta
and, group 2 (n = 20), to ingest a placebo capsule devoid of the bacterial strain. The trial lasted for 16 weeks, with hospital visits at baseline (V1) and at the end of the study (V2).
Sponsors
Exeltis Healthcare
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women between 18 and 45 years of age 2. Endometriosis diagnosed by clinical criteria: visual tests, ultrasound, symptomatology (including pelvic pain, with a score = 3 on the NRS scale) 3. Women of childbearing age must have a negative pregnancy test prior to inclusion in the study and must commit to oral contraceptive treatment containing a progestin (dienogest 2 mg) for the entire duration of the study and continue until the end of indicated treatment 4. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Current BMI> 30 kg/m2 2. Any known endometrial pathology other than endometriosis. 3. Polycystic ovary syndrome 4. Ovulatory dysfunction 5. Immunosuppression 6. Patients with severe acute or chronic disease (e.g., pancreatitis, hypertriglyceridemia, liver disease, benign or malignant liver tumor, sex hormone-dependent genital or breast malignancies) 7. History of serious cardiovascular events 8. Uncontrolled hypertension or diabetes 9. Hypersensitivity, allergy or known intolerance to any of the components of the products under investigation. 10. Consumption of medications, complements or food supplements that could have an impact on the development of the study, such as antibiotics, other pro- and prebiotics, laxatives, etc. during the course of the study 11. Undiagnosed abnormal vaginal bleeding 12. Clinical evidence of neuropathy 13. History of pelvic inflammatory diseases 14. Patients with autoimmune diseases (including Crohn's disease) 15. Pregnancy and/or breastfeeding for the duration of the study 16. Postmenopausal patients 17. Participation in any other clinical trial 30 days prior to the start of the study 18. Women who, at the investigator's discretion, do not present the conditions to be able to participate in the study safely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures are assessed at baseline (V1) and the end of the study (V2): 1. Vaginal microbiota measured by DNA extraction from vaginal samples and sequence analysis using the Illumina MiSeq pair-end protocol 2. Inflammation, captured via the immunological analysis of serum levels of interleukin (IL)-8, IL-10, tumoral necrosis factor (TNF)-a, vascular endothelial growth factor A (VEGF-A), and transforming growth factor ß2 (TGF-ß2) using a Luminex XMAP™ Technology analyser | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline (V1) and the end of the study (V2): 1. Quality of life measured using the Endometriosis Health Profile-30 (EHP-30) questionnaire 2. Serum 17ß-estradiol levels were measured using an immunoassay by chemiluminometric technology performed in an Atellica® IM analyzer | — |
Countries
Spain
Contacts
Public ContactPedro Antonio Regidor
Outcome results
None listed