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

NCT07647198 | Recruiting Phase 2 DMC

• 2 other identifiers: SSMCCREC-678DOH/ADHRTC/2025/1994
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Fibroids (Leiomyoma)

Keywords

Uterine fibroids; EGCG; Vitamin D3; Myomectomy

Outcome Measures

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.

  2 years

Secondary Outcomes (6)

• Return of moderate to heavy menses

  2 years

• Need for reintervention

  2 years

• Time to event

  2 years

• Symptom recurrence

  2 years

• Return of pelvic pain

  2 years

Study Arms (2)

Investigational arm

EXPERIMENTAL

Treatment with EGCG and vitamin D3 tablets for up to 2 years following surgical myomectomy. Each tablet contains 150 mg EGCG and 1000 IU vitamin D3, and participants will take one tablet twice daily, providing a total daily dose of 300 mg EGCG and 2000 IU vitamin D3 (n=160).

Combination Product: Vitamin D and Green Tea

Placebo arm

PLACEBO COMPARATOR

Treatment with placebo after surgical myomectomy (n=80).

Other: Placebo

Interventions

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

Investigational arm

Placebo OTHER

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

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological females, born as females. Males are not allowed to participate. Therefore, only biologically female participants with a uterus are eligible for inclusion.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic (from the standing position) or atraumatic fracture (toe, finger, skull, face, and ankle fractures are allowed). A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the patient's bone mineral density is within normal limits.
• Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss
• Anticipated use of systemic glucocorticoids at an oral prednisone-equivalent dose of more than 5 mg every other day during the study. Note: topical, inhaled, intranasal, optic, ophthalmic, intraarticular, or intralesional subcutaneous are permitted without restriction.
• Gastrointestinal disorder affecting absorption or gastrointestinal motility
• Has jaundice or known current active liver disease from any cause, including hepatitis A (HAV IgM), hepatitis B (HBsAg), or hepatitis C (HCV Ab positive, confirmed by HCV RNA).
• Has any of the following cervical pathology: high-grade cervical neoplasia, atypical glandular cells, atypical endocervical cells, atypical squamous cells favoring high grade. Of note, patients with atypical squamous cells of undetermined significance and low-grade cervical neoplasia may be included in the study if high-risk human papillomavirus testing is negative or if DNA testing for human papillomavirus 16 and 18 DNA testing is negative
• Has any history of clinical laboratory abnormalities indicating hepatic or gallbladder impairment.
• Has been a participant in an investigational drug or device study within the 1 month prior to the screening visit.
• Has a history of clinically significant condition(s) including, but not limited to:
• Untreated thyroid dysfunction or palpable thyroid abnormality (patients with adequately treated hypothyroidism who are stable on medication are not excluded).
• History of malignancy within the past 5 years or ongoing malignancy other than curatively treated nonmelanoma skin cancer or surgically cured Stage 0 in situ melanoma.

Sponsors & Collaborators

• Sheikh Shakhbout Medical City: lead

Study Sites (1)

Sheikh Shakbhout Medical City

Abu Dhabi, United Arab Emirates (uae), 00000, United Arab Emirates

RECRUITING

Related Publications (9)

• Sharan C, Halder SK, Thota C, Jaleel T, Nair S, Al-Hendy A. Vitamin D inhibits proliferation of human uterine leiomyoma cells via catechol-O-methyltransferase. Fertil Steril. 2011 Jan;95(1):247-53. doi: 10.1016/j.fertnstert.2010.07.1041. Epub 2010 Aug 23.

  PMID: 20736132 BACKGROUND

• Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, Critchley HOD, Li Y, McKain L, Arjona Ferreira JC, Langenberg AGM, Wagman RB, Stewart EA. Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy. N Engl J Med. 2021 Feb 18;384(7):630-642. doi: 10.1056/NEJMoa2008283.

  PMID: 33596357 BACKGROUND

• Halder SK, Goodwin JS, Al-Hendy A. 1,25-Dihydroxyvitamin D3 reduces TGF-beta3-induced fibrosis-related gene expression in human uterine leiomyoma cells. J Clin Endocrinol Metab. 2011 Apr;96(4):E754-62. doi: 10.1210/jc.2010-2131. Epub 2011 Feb 2.

  PMID: 21289245 BACKGROUND

• Vafaei S, Ciebiera M, Omran MM, Ghasroldasht MM, Yang Q, Leake T, Wolfe R, Ali M, Al-Hendy A. Evidence-Based Approach for Secondary Prevention of Uterine Fibroids (The ESCAPE Approach). Int J Mol Sci. 2023 Nov 4;24(21):15972. doi: 10.3390/ijms242115972.

  PMID: 37958957 BACKGROUND

• Roshdy E, Rajaratnam V, Maitra S, Sabry M, Allah AS, Al-Hendy A. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study. Int J Womens Health. 2013 Aug 7;5:477-86. doi: 10.2147/IJWH.S41021. eCollection 2013.

  PMID: 23950663 BACKGROUND

• Halder SK, Sharan C, Al-Hendy A. 1,25-dihydroxyvitamin D3 treatment shrinks uterine leiomyoma tumors in the Eker rat model. Biol Reprod. 2012 Apr 19;86(4):116. doi: 10.1095/biolreprod.111.098145. Print 2012 Apr.

  PMID: 22302692 BACKGROUND

• Zhang D, Al-Hendy M, Richard-Davis G, Montgomery-Rice V, Sharan C, Rajaratnam V, Khurana A, Al-Hendy A. Green tea extract inhibits proliferation of uterine leiomyoma cells in vitro and in nude mice. Am J Obstet Gynecol. 2010 Mar;202(3):289.e1-9. doi: 10.1016/j.ajog.2009.10.885. Epub 2010 Jan 13.

  PMID: 20074693 BACKGROUND

• Zhang D, Al-Hendy M, Richard-Davis G, Montgomery-Rice V, Rajaratnam V, Al-Hendy A. Antiproliferative and proapoptotic effects of epigallocatechin gallate on human leiomyoma cells. Fertil Steril. 2010 Oct;94(5):1887-93. doi: 10.1016/j.fertnstert.2009.08.065. Epub 2009 Oct 12.

  PMID: 19819432 BACKGROUND

• Zhang D, Rajaratnam V, Al-Hendy O, Halder S, Al-Hendy A. Green tea extract inhibition of human leiomyoma cell proliferation is mediated via catechol-O-methyltransferase. Gynecol Obstet Invest. 2014;78(2):109-18. doi: 10.1159/000363410. Epub 2014 Jun 18.

  PMID: 24942317 BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Interventions

Vitamin D; Tea

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ayman Al Hendy, M.D. Ph.D.

  Sheikh Shakbhout Medical City

  PRINCIPAL INVESTIGATOR

• Basel Imam, M.D.

  Sheikh Shakbhout Medical City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tonianne J Grobmyer, Physician Associate

CONTACT

800; tonianne.grobmyer@ku.ac.ae

Leen Oyoun Alsoud, Master Pharmaceutical Sciences

CONTACT

+971 800 7762; 100066957@ku.ac.ae

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigational product (EGCG 300 mg and vitamin D3 2000 IU) and placebo tablets will be identical in appearance, packaging, labeling, and administration schedule to maintain blinding. Randomization will be implemented at Sheikh Shakbhout Medical City (SSMC). Allocation codes will be concealed and accessible only to the designated statistician and the study pharmacist responsible for dispensing. Unblinding will only occur in the event of a medical emergency where knowledge of treatment allocation is required for participant safety.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD FRCSC FACOG CCRP Consultant OBGYN

Model Details: Type of study: A randomized double-blind trial Randomization: it will be done using computer-generated random numbers and the method of permuted blocks. It will be implemented using the REDCap randomization module. Two hundred and forty (240) eligible patients will be assigned to one of the following arms: 1. Treatment with EGCG and Vitamin D3 (300mg, 2000 IU respectively, in tablets), up to 2 years after surgical myomectomy. (Each tablet will contain 150 mg EGCG, 1000 IU Vitamin D3 (n=160). 2. Treatment with placebo after surgical myomectomy (n=80).

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 22, 2026
• Primary Completion (Estimated): August 22, 2029
• Study Completion (Estimated): December 22, 2029
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)