Uterine fibroids Urological and Genital Diseases
Conditions
Interventions
A randomised, double-blind, parallel, two-arm, placebo-controlled study will be conducted to evaluate the efficacy and safety of a dietary supplement rich in omega-3 fatty acids, vitamin D and vitamin
active/cap: 150 mg EPA
DHA (200–450 mg/g)
active/cap: 240 mg DHA
17-HDHA (80–400 mg/kg)
active/cap: 180 µg 17-HDHA
18-HEPE (50–400 mg/kg)
active/cap: 168 µg 18-HEPE
14-HDHA (40–200 mg/kg)
active/cap: 90 µg 14-HDHA
Total: 750,000 mg/cap
Cholecalciferol (Vitamin D3) 1,000,000 IU/g
2,000 mg/cap
active/cap: 50 µg Vit D (2000 IU)
Pyridoxine hydrochloride (82.26% Vitamin B6)
12.157 mg/cap
active/cap: 10 mg Vit B6
EPA = eicosapentaenoic acid, DHA = docosahexaenoic acid
17-HDHA = 17-hydroxy-docosahexaenoic acid
18-HEPE = 18-hydroxy-eicosapentaenoic acid
14-HDHA = 14-hydroxy-docosahexaenoic acid
Group 1: Nutritional supplement
"UTERINE FIBROIDS" capsules. One capsule will be administered every 24 hours for 4 months.
Group 2: Placebo
Placebo capsules
Sponsors
Laboratorios Liconsa S.A.
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Women over 18 years of age until menopause 2. Uterine myoma =2 cm³ detected and documented by vaginal ultrasound 3. Abnormal uterine bleeding (AUB) as perceived by the patient and/or dysmenorrhoea 4. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with severe acute or chronic diseases (e.g., pancreatitis, hypertriglyceridaemia, liver disease, benign or malignant liver tumour, malignant diseases in the genitals or breasts dependent on sex hormones) 2. Use of drugs that induce microsomal enzymes, especially cytochrome P450, such as phenytoin, phenobarbital, primidone, bosentan, carbamazepine, rifampicin, topiramate, felbamate, griseofulvin, some HIV protease inhibitors (e.g., ritonavir), and non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz), as well as St John's wort preparations 3. Active venous thromboembolic disorder or history of thromboembolic events 4. Past or present arterial and cardiovascular disease (e.g., myocardial infarction, stroke, ischaemic heart disease) 5. Use of anticoagulant medication 6. Known hypersensitivity to vitamin D and/or B6 and/or SPMs 7. Undiagnosed abnormal vaginal bleeding 8. Use of medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir during and 2 weeks prior to study entry 9. Patients using intrauterine devices (IUDs) or intrauterine systems (IUSs) 10. Use of selective progesterone receptor modulators (ulipristal) or GnRH antagonists (ganirelix, centrorelix) or agonists (buserelin, goserelin, leuprorelin, triptorelin) in the last 6 months 11. Pregnancy and breastfeeding throughout the duration of the study 12. Postmenopausal patients 13. Participation in any other clinical trial 30 days prior to study commencement
Countries
Spain
Contacts
Public ContactPedro Antonio Regidor
Outcome results
None listed