FATIMA Trial: EGCG and Vitamin D3 for Secondary Prevention of Uterine Fibroids
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.
• 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.
• Has at least one or more of the following symptoms:
‣ Moderate to heavy menses defined as PBAC score ≥ 120
⁃ Pelvic pain during menses measured on NRS ≥ 4 at baseline
⁃ Moderately severe fibroid-related symptoms (a score ³ 25 on the UF quality of life symptoms severity subscale).
• Has a negative urine pregnancy test at the Screening, Baseline, and interval clinic visits
• Agrees to not be pregnant for at least 12 months. Participants may use any form of non-hormonal contraception consistently during the screening period and the randomized treatment period. These may include Diaphragm, cervical cap, spermicides, male and female condoms, copper IUD and sponge. Each one will be explained in detail for the participants. However, the patient is not required to use contraception if she:
‣ Has a sexual partner(s) who was vasectomized at least 6 months before the screening period.
⁃ Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 4 months prior to the first screening visit (patients with Essure™ must have prior confirmation of tubal occlusion by hysterosalpingogram).
⁃ Is not sexually active with men; periodic sexual relationship(s) with men requires the use of dual non-hormonal contraception as noted above; or
⁃ Practices total abstinence from sexual intercourse as her preferred lifestyle; periodic abstinence is not acceptable.
• Has an endometrial (aspiration) biopsy, if clinically indicated, performed during the screening period, with results showing no clinically significant endometrial pathology (hyperplasia, endometritis, or endometrial cancer).