Clinical trial to evaluate the effect of a nutritional supplement based on omega 3 fatty acids bleeding and quality of life in women with uterine fibroids
| ISRCTN | ISRCTN69006251 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69006251 |
| Sponsor | Laboratorios Liconsa S.A. |
| Funder | Insud Pharma |
- Submission date
- 18/02/2026
- Registration date
- 18/02/2026
- Last edited
- 18/02/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
This study aims to evaluate the effect of a dietary supplement rich in omega-3 fatty acids, vitamin D, and vitamin B6 on symptoms associated with uterine fibroids (non-cancerous growths of the uterus), as well as fibroid size.
Who can participate?
Women aged from 18 years of age until menopause who have uterine fibroids, abnormal uterine bleeding and/or dysmenorrhoea (period pain)
What does the study involve?
Participants are randomly allocated to one of two groups:
Group 1: "UTERINE FIBROIDS" capsules. One capsule will be taken every 24 hours for 4 months.
Group 2: Placebo capsules. One capsule will be taken every 24 hours for 4 months.
What are the possible benefits and risks of participating?
There may be an improvement in uterine fibroid associated symptoms.
Where is the study run from?
Laboratorios Liconsa S.A., a subsidiary of Insud Pharma (Spain)
When is the study starting and how long is it expected to run for?
July 2024 to May 2025
Who is funding the study?
Laboratorios Liconsa S.A., a subsidiary of Insud Pharma (Spain)
Who is the main contact?
Prof. Dr. med. Pedro-Antonio Regidor, pedro-antonio.regidor@exeltis.com
Contact information
Scientific, Public, Principal investigator
Adalperostr. 84
Ismaning
85737
Germany
| Phone | +44 (0)1738938132 |
|---|---|
| pedro-antonio.regidor@exeltis.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | Basic science, Health services research, Supportive care | |
| Scientific title | Placebo-controlled clinical trial to evaluate the effect of a nutritional supplement containing vitamin D, vitamin B6 and pro-resolving specialised mediators on uterine fibroids | |
| Study acronym | EMY-1 | |
| Study objectives | To evaluate the effect of a dietary supplement rich in omega-3 fatty acids, vitamin D, and vitamin B6 on symptoms associated with uterine fibroids, as well as fibroid size. | |
| Ethics approval(s) |
Approved 18/04/2024, Research Ethics Committee for Medicines at HM Hospitals (Avda. Montepríncipe, 25, Boadilla del Monte, 28660, Spain; +34 (0)91 708 99 00, ext 12588; secretariaceic@mail.hmhospitales.com), ref: Código CEIm HM Hospitales: 24.04.1985E5-GHM | |
| Health condition(s) or problem(s) studied | Uterine fibroids | |
| Intervention | 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 B6 in patients with uterine fibroids by assessing the size and symptoms associated with fibroids, as well as the hypothalamic-pituitary-gonadal axis. The investigational product and placebo will be manufactured and packaged by Laboratorios Liconsa SL. The label of the investigational food supplement will comply with local laws and regulations. The information on the labels will be in Spanish. During the study, the investigational products must be stored at room temperature, always below 30°C. The following table shows the qualitative and quantitative composition of the nutritional supplement: Ingredients: EPA (100–300 mg/g); 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. One capsule will be administered every 24 hours for 4 months. | |
| Intervention type | Supplement | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 01/05/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 50 |
| Total final enrolment | 59 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2024 |
| Date of final enrolment | 02/12/2024 |
Locations
Countries of recruitment
- Spain
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
18/02/2026: Study's existence confirmed by the Research Ethics Committee for Medicines at HM Hospitals.
