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Prevention study for Uterine Fibroids (Leiomyoma)
Official title FATIMA Trial: EGCG and Vitamin D3 for Prevention of Fibroid Recurrence
ClinicalTrials.gov ID: NCT07647198
What this study is testing
What is Vitamin D and Green Tea?
Vitamin D and Green Tea is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for uterine fibroids (leiomyoma).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- (all must have been met before randomization unless otherwise specified and exceptions to may be made at the discretion of the Principal...
- 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...
- Has at least one or more of the following symptoms:
You likely can't join 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...
- 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...
- Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia...
- Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and...
See the full eligibility criteria
Who can join
- (all must have been met before randomization unless otherwise specified and exceptions to may be made at the discretion of the Principal Investigator, provided they are justified and ensure no compromise to the study's...
- 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 assigned by chance treatment period. These may include...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- Any current psychiatric disorder that would, in the opinion of the investigator or medical monitor, impair the ability of the patient to participate in the study or would impair the interpretation of their data...
- Has a prior (within 1 year of Screening 1 visit) or current history of drug or alcohol abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders V (all patients must be questioned about their...
- Has participated in a previous clinical study that included the use of Green tea or Vitamin D3 or has received this treatment within 3 months of the study.
- Is inappropriate for participation in this study for other reasons, as determined by the investigator, sub-investigator, or medical monitor.
The study team makes the final eligibility decision.
Where it's taking place
- Abu Dhabi, United Arab Emirates (uae), United Arab Emirates
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Abu Dhabi, United Arab Emirates (uae), United Arab Emirates. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.