Health TrialsbyHealthPanel

FATIMA Trial: EGCG and Vitamin D3 for Prevention of Fibroid Recurrence

ConditionUterine Fibroids (Leiomyoma)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSheikh Shakhbout Medical City

About this trial

The aim of this randomized controlled clinical trial is to evaluate the efficacy of green tea (EGCG) and vitamin D3 supplementation in preventing uterine fibroid recurrence following fibroid removal.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has voluntarily signed and dated the informed consent form before initiation of any screening or study-specific procedures.

Premenopausal females aged 18 years and older on the day of signing of the informed consent form.

Has a diagnosis of uterine fibroids that is confirmed by a pelvic ultrasound (transvaginal and/or transabdominal) performed during the screening period.

Moderate to heavy menses defined as PBAC score ≥ 120

Disqualifiers

Participants with documented vitamin D deficiency (based on previous serum vitamin D level within prior 12 months).

Has transvaginal and/or transabdominal ultrasound during the screening period demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patient's heavy menstrual bleeding, such as uterine or cervical polyps > 2.0 cm, or any other clinically significant gynecological disorder determined by the investigator to require further evaluation and/or treatment.

Has unexplained vaginal bleeding outside of the patient's regular menstrual cycle.

Has undergone ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, as well as endometrial ablation for abnormal uterine bleeding within 6 months prior to the screening visit.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin D and Green Tea

    Combination product

    EGCG and Vitamin D3 (300 mg, 2000 IU respectively, in tablets Each tablet will contain 150 mg EGCG, 1000 IU Vitamin D

  • Placebo

    Other intervention

    The placebo has no medication and the participant will receive standard of care.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Investigational armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fibroid Recurrence

The primary outcome is: Fibroid recurrence when compared to the post-myomectomy baseline pelvic ultrasound (transvaginal and/or transabdominal), defined as a new fibroid identified on ultrasound with volume \>1 cm3.

Time frame
2 years

Secondary outcomes

1

Return of moderate to heavy menses

Return of moderate to heavy menses defined as PBAC score ≥ 120 for patients with pre-operative moderate to heavy menses. PBAC stands for Pictorial Blood Loss Assessment Chart. In this chart, there is no unit. In this Chart, the higher the number, the heavier the menses.

Time frame
2 years
2

Need for reintervention

Need for reintervention defined as the need to undergo a procedure or surgery for treatment of uterine fibroids including repeat myomectomy, uterine fibroid embolization, and radiofrequency ablation. In this outcome, we will examine the participant info at each evaluation visit to capture the data if she has undergone any anti-fibroid procedure or surgery. The captured data will be: "Yes" or "No".

Time frame
2 years
3

Time to event

Time to event (procedure or surgery) such as radiofrequency ablation (RFA), myomectomy, hysterectomy, or uterine fibroid embolization (UFE). The unit for this outcome is "weeks". In this outcome, we will examine the patient info at each evaluation visit to calculate the number of "weeks" it took a participant to need to undergo an anti-fibroid procedure or surgery.

Time frame
2 years
4

Symptom recurrence

Symptom recurrence according to the Uterine fibroid quality of life symptoms severity subscale. There is no unit for this outcome. Higher score values are indicative of greater symptom severity and lower scores will indicate minimal symptom severity.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sheikh Shakhbout Medical City

Lead sponsor

Source ClinicalTrials.gov
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