AzTrials
AzTrials

Uterine LeiomyomaEarly Phase 1NCT06959966

Effects of Oligo-fucoidan on Leiomyoma Patients

A Early Phase 1 study testing Oligo Fucoidan in people with Uterine Leiomyoma, run by Taipei Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 55 years, women only
Conditions the study is for
Uterine Leiomyoma
What is being tested?
Oligo Fucoidan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteTaiwan
Study dates
14 Aug 2019to 31 Jan 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Medical Univeersity

    Taipei, Xinyi, 110

Other trials in Taiwan

About this study

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.

Being tested
Placebo, Oligo Fucoidan
Medical subject headings
Myofibroma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboCombination product

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

  • Oligo FucoidanCombination product

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

Study groups in NCT06959966
Study groupRoleWhat they receive
PlaceboPlacebo comparatorStarch capsule, 4 grams per day (two capsules), taken orally for six months. Capsules match the treatment group in odor and weight.
Receives: Combination Product: Placebo
TreatmentExperimentalOligo-Fucoidan capsule, 4 grams per day (two capsules), taken orally for six months.
Receives: Combination Product: Oligo Fucoidan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Leiomyoma Size

    the size of leiomyoma tissue (mm)

    Measured: 6 months

  2. Change in Number of Leiomyomas

    the number of leiomyoma tissue

    Measured: 6 months

Secondary outcomes (15)

  1. Change in Triglyceride Level

    TG (triglycerides): mg/dL

    Measured: 6 months

  2. Change in Total Cholesterol Level

    T-CHO (total cholesterol): mg/dL

    Measured: 6 months

  3. Change in HDL Cholesterol Level

    HDL-C (high-density lipoprotein cholesterol): mg/dL

    Measured: 6 months

  4. Change in LDL Cholesterol Level

    LDL-C (low-density lipoprotein cholesterol): mg/dL

    Measured: 6 months

  5. Change in White Blood Cell Count

    WBC (white blood cells), Unit: 10³/μL

    Measured: 6 months

  6. Change in Red Blood Cell Count

    RBC (red blood cells), Unit: 10⁶/μL

    Measured: 6 months

  7. Change in Hemoglobin Level

    HGB (hemoglobin) Unit: g/dL

    Measured: 6 months

  8. Change in Hematocrit

    HCT (hematocrit) Unit: %

    Measured: 6 months

  9. Change in Blood Glucose

    Measurement: AC (blood glucose) Unit: mg/dL

    Measured: 6 months

  10. Change in High-Sensitivity C-Reactive Protein

    High-Sensitivity C-Reactive Protein (HS-CRP) Unit: mg/dL

    Measured: 6 months

  11. Change in Aspartate Aminotransferase

    Aspartate Aminotransferase(AST) Unit: U/L

    Measured: 6 months

  12. Change in Alanine Aminotransferase

    Alanine Aminotransferase (ALT) Unit: U/L

    Measured: 6 months

  13. Change in Blood Urea Nitrogen

    Blood Urea Nitrogen (BUN) Unit: mg/dL

    Measured: 6 months

  14. Change in Follicle-Stimulating Hormone

    Follicle-Stimulating Hormone(FSH) Unit: mIU/mL

    Measured: 6 months

  15. Change in Albumin

    Albumin (ALB) Unit: g/dL

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start14 Aug 2019
  3. Primary completion1 Dec 2022
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06959966
Sponsor's protocol ID
N201812056
Status last verified
Mar 2025
First submitted
14 Mar 2025
Last updated
7 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Oligo Fucoidan in people with Uterine Leiomyoma, run by Taipei Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Leiomyoma Size (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06959966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in