NCT06959966

Effects of Oligo-fucoidan on Leiomyoma Patients

Completed EARLY_PHASE1 Last updated 7 May 2025

What this trial tests

EARLY_PHASE1 trial testing Placebo in Uterine Leiomyoma in 18 participants. Completed in 31 January 2023.

Timeline

14 August 2019

Primary endpoint
1 December 2022

31 January 2023

Quick facts

Lead sponsor	Taipei Medical University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	18
Start date	14 August 2019
Primary completion	1 December 2022
Estimated completion	31 January 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• Placebo
• Oligo Fucoidan

Conditions studied

• Uterine Leiomyoma — all drugs for Uterine Leiomyoma →

Sponsor

Taipei Medical University

Who can join

Adults 20 to 55, female only, with Uterine Leiomyoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Uterine leiomyoma is the most common benign tumor in women, with an incidence rate of approximately 20% among women of reproductive age. Patients may experience severe abdominal pain, abnormal bleeding, and infertility. Pathological examination of uterine specimens reveals that up to three-quarters of cases involve uterine leiomyoma, indicating that this condition is often accompanied by other uterine pathologies. Therefore, medical intervention remains necessary for affected patients. Currently, the most common treatment options include medication and surgical removal. However, the severe side effects of drug therapy and the high recurrence rate following surgical excision significantly impact patients' quality of life, underscoring the need for continued research into better treatment strategies. Fucoidan, a commercially available dietary supplement, has been shown in numerous studies to provide adjunctive therapeutic benefits for cancer patients. However, no clinical trials have been conducted to evaluate the effects of fucoidan on patients with uterine leiomyoma. Therefore, this clinical study aims to investigate the effects of fucoidan on patients with uterine leiomyoma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Marine Oligo-Fucoidan as a Safe Functional Food for Managing Uterine Fibroids: Results from a Pilot Randomized Controlled Trial.
   Chiang YF, Huang KC, Huang PS, Ali M, et al · · 2025 · PMID 40868223 · DOI 10.3390/biomedicines13081970