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New drug combo aims to shrink fibroids in pregnant women

NCT ID NCT04762316

Disease control Sponsor: Trieu, Nguyen Thi, M.D. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called SB-UF, which combines hormones and a plant extract, to see if it can shrink uterine fibroids in pregnant women. 66 women took the drug or a placebo throughout their pregnancy. The goal was to reduce fibroid size and help them disappear, which could make pregnancy safer and healthier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SB-UF (pregnenolone, pyridoxal phosphate, dydrogesterone, and Impatiens balsamina extract)
What this could lead to
If it works, this could offer a way to shrink uterine fibroids during pregnancy, potentially reducing complications and improving pregnancy outcomes.
What could go wrong
This is a small, completed Phase 4 trial with only 66 participants. Results may not apply to all women, and the combination of hormones and plant extracts may have side effects or limited effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

66 people

The number who actually took part.

Started

Jan 2019

Finished

Dec 2025

Lead sponsor

An individual researcher

The lead sponsor is a named person rather than an organisation.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Procedure to the treatment of fibroids in pregnancy and in women desiring future fertility. Exclusion Criteria: * Subserosal fibroids may be pedunculated hanging from a stalk inside or outside the uterus.

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Conditions

The condition(s) this trial relates to.

uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uterine fibroids affecting pregnancy

Contacts and locations

Locations

  • Saigon Biopharma Company Limited

    Ho Chi Minh City, 700000, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.