NCT06959966

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2019

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
Last Updated

May 7, 2025

Status Verified

March 1, 2025

Enrollment Period

3.3 years

First QC Date

March 14, 2025

Last Update Submit

May 4, 2025

Conditions

Uterine Leiomyoma

Outcome Measures

Primary Outcomes (2)

  • Change in Leiomyoma Size

    the size of leiomyoma tissue (mm)

    6 months

  • Change in Number of Leiomyomas

    the number of leiomyoma tissue

    6 months

Secondary Outcomes (15)

  • Change in Triglyceride Level

    6 months

  • Change in Total Cholesterol Level

    6 months

  • Change in HDL Cholesterol Level

    6 months

  • Change in LDL Cholesterol Level

    6 months

  • Change in White Blood Cell Count

    6 months

  • +10 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Starch capsule, 4 grams per day (two capsules), taken orally for six months. Capsules match the treatment group in odor and weight.

Combination Product: Placebo

Treatment

EXPERIMENTAL

Oligo-Fucoidan capsule, 4 grams per day (two capsules), taken orally for six months.

Combination Product: Oligo Fucoidan

Interventions

PlaceboCOMBINATION_PRODUCT

Starch capsule, 4 grams, two capsules per day for six months.

Placebo
Oligo FucoidanCOMBINATION_PRODUCT

Oligo fucoidan capsule, 4 grams, two capsules per day for six months.

Treatment

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsLeiomyoma patients
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with uterine fibroids aged 20-55 years.
  • Confirmation of uterine fibroids by ultrasound (more than 3 cm, less than 10 cm).
  • There are no plans for pregnancy in the past six months.
  • There were no plans for uterine fibroid surgery for nearly six months.
  • Agree to abide by the research regulations.

You may not qualify if:

  • A patient with heart disease, liver disease, kidney disease or any mental illness.
  • Patients who are unable to communicate or criticize.
  • Pregnant women.
  • Patients taking regular medications, including serotonin, antidepressants or other antipsychotics.
  • Non-native speakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical Univeersity

Taipei, Xinyi, 110, Taiwan

Location

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

May 7, 2025

Study Start

August 14, 2019

Primary Completion

December 1, 2022

Study Completion

January 31, 2023

Last Updated

May 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)