Uterine Fibroids Affecting PregnancyPhase 4SB-UFNCT04762316
Composition for Treating Uterine Fibroid (SB-UF)
A Phase 4 study testing SB-UF in people with Uterine Fibroids Affecting Pregnancy, run by Trieu, Nguyen Thi, M.D. at 1 site in Vietnam.
Trial summary
Pregnenolone \& Pyridoxal Phosphate SB-UF for treating uterine fibroids in women's pregnancies to lose the size of fibroids and to dissolve fibroids. Uterine fibroids are a very common finding in women pregnancy of reproductive age, fibroids fast grow in the first trimester of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Uterine Fibroids Affecting Pregnancy
- What is being tested?
- SB-UF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2019to 31 Dec 2025
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Procedure to the treatment of fibroids in pregnancy and in women desiring future fertility.
Who cannot join
- Subserosal fibroids may be pedunculated hanging from a stalk inside or outside the uterus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Fibroids Are a Prevalent Finding in Women of Reproductive Age. Ready Safety Study Extracts of Plants Pregnenolone, Pyridoxal Phosphate, and Dydrogesterone for Treating Uterine Fibroids in Women's Pregnancy.
Pregnenolone \& Pyridoxal Phosphate SB-UF for treating uterine fibroids in women's pregnancies to lose the size of fibroids and to dissolve fibroids.
Uterine fibroids are a very common finding in women pregnancy of reproductive age, fibroids fast grow in the first trimester of pregnancy. SB-UF against the rapid growth of fibroids under the influence of hormones during pregnancy. Use SB-UF to think about regulating stable Oestrogen levels and dissolving fibroids.
This is a substantial insight into disease pathogenesis, with a clear path toward clinical application, which would lead to a substantial advance and perfection in management or public health policy.
Read the detailed description
Uterine fibroids are a very common finding in women's pregnancy of reproductive age fibroids fast grow in the first trimester of pregnancy.
Clinically has shown that:
- Uterine fibroids are associated with heavy or prolonged menstrual periods, and abnormal bleeding between menstrual periods.
- Fibroids are associated with increased rates of spontaneous miscarriage, premature birth, placenta ablation, malpresentation, labor dysfunction, cesarean section, and postpartum hemorrhage, pain is the most common complication of fibroids uterus during pregnancy.
- Use the composition that has sufficient Pregnenolone, and coenzyme Pyridoxal Phosphate, and combined with Dydrogesterone, this preparation will soften uterine fibroids and disappear fibroids.
Pregnenolone is produced in the adrenal glands and the central nervous system. Pregnenolone is synthesized from Cholesterol and it is the precursor of Progesterone, Estrogen, and dehydroepiandrosterone (DHEA). In some people Pregnenolone will decrease with age, which will lead to an imbalance between Progesterone and estrogen, according to research, this imbalance is the cause of abnormal growth of the uterine muscle fibers cells that produce multiple fibroids in the womb. Supplementation Pregnenolone is necessary for women of childbearing and reproductive age, overtime tracking pregnant women but there were fibroids from before pregnancy these fibroids will develop very quickly to stun the fetus many problems in pregnancy, and childbirth, the risk of miscarriage, preterm delivery,...The new drug will maintain a sufficient amount of Pregnenolone natural is the essence from Dioscorea persimilis prain \& burkill and associated with a necessary element is Coenzyme Pyridoxal Phosphate, Dydrogesterone. Compound presence in the body will curb the development of the muscle fibers uterus, the muscle fibers in the fibroids will soften, spread out, and disappear fibroids. The uterus returns to its normal state, the fetus will develop naturally.
Research results
- After 40 weeks of ultrasound examination:
- 100% of women using SB-UF drugs have the disappearance of fibroids, only the image of uterine muscle is thicker than usual.
- 100% of women who received SB-UF placebo did not experience any beneficial progress.
- Through study completion, an average of 40 weeks
- Conditions
- Uterine Fibroids Affecting Pregnancy
- Being tested
- SB-UF, SB-UF Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-UFDrug
Also called Pregnenolone 60mg & Pyridoxal Phosphate 20mg & Dydrogesterone 10mg & Impatien balsamina extract 100 mg
Dosage:
-Take 1tablet/2 times/day/in throughout pregnancy.
SB-UF PlaceboDevice
Also called Pregnenolone & Pyridoxal Phosphate Placebo
Dosage:
-Take 1tablet/2 times/day/in throughout pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| SB-UF Drug | Experimental | Use SB-UF drugs to lose the size of Uterine Fibroids on Women the Pregnancy. Measuring the size of uterine fibroid. Monitor the disappearance of uterine fibroids from 4 - 40 weeks Receives: Drug: SB-UF |
| SB-UF Placebo | Placebo comparator | Use SB-UF placebo to lose the size of Uterine Fibroids on Women the Pregnancy. Measuring the size of uterine fibroid. Monitor the disappearance of uterine fibroids from 4 - 40 weeks Receives: Device: SB-UF Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use SB-UF drugs to lose the size of Uterine Fibroids on Women the Pregnancy.
Measuring the size of uterine fibroid. Monitor the disappearance of benign smooth muscle cell tumors of the uterus
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids Affecting PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Selection of women ages 18 to 40, with pregnancy uterine fibroids and pregnancy in the 8th week of pregnancy.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Responsible party
- Sponsor
- Investigators
- Thi Trieu Nguyen, Dr., Principal investigator, Trieu, Nguyen Thi, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762316
- Sponsor's protocol ID
- Removal the Uterine Fibroids
- Acronym
- SB-UF
- Status last verified
- Jun 2026
- First submitted
- 3 Jan 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Fibroids Are a Prevalent Finding in Women of Reproductive Age. Ready Safety Study Extracts of Plants Pregnenolone, Pyridoxal Phosphate, and Dydrogesterone for Treating Uterine Fibroids in Women's Pregnancy.
- ClinicalTrials.gov ID
- NCT04762316
- Acronym / sponsor ID
- SB-UF / Removal the Uterine Fibroids
- Conditions
- Uterine Fibroids Affecting Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnenolone \& Pyridoxal Phosphate SB-UF for treating uterine fibroids in women's pregnancies to lose the size of fibroids and to dissolve fibroids.
Uterine fibroids are a very common finding in women pregnancy of reproductive age, fibroids fast grow in the first trimester of pregnancy. SB-UF against the rapid growth of fibroids under the influence of hormones during pregnancy. Use SB-UF to think about regulating stable Oestrogen levels and dissolving fibroids.
This is a substantial insight into disease pathogenesis, with a clear path toward clinical application, which would lead to a substantial advance and perfection in management or public health policy.
Detailed description
Uterine fibroids are a very common finding in women's pregnancy of reproductive age fibroids fast grow in the first trimester of pregnancy.
Clinically has shown that:
- Uterine fibroids are associated with heavy or prolonged menstrual periods, and abnormal bleeding between menstrual periods.
- Fibroids are associated with increased rates of spontaneous miscarriage, premature birth, placenta ablation, malpresentation, labor dysfunction, cesarean section, and postpartum hemorrhage, pain is the most common complication of fibroids uterus during pregnancy.
- Use the composition that has sufficient Pregnenolone, and coenzyme Pyridoxal Phosphate, and combined with Dydrogesterone, this preparation will soften uterine fibroids and disappear fibroids.
Pregnenolone is produced in the adrenal glands and the central nervous system. Pregnenolone is synthesized from Cholesterol and it is the precursor of Progesterone, Estrogen, and dehydroepiandrosterone (DHEA). In some people Pregnenolone will decrease with age, which will lead to an imbalance between Progesterone and estrogen, according to research, this imbalance is the cause of abnormal growth of the uterine muscle fibers cells that produce multiple fibroids in the womb. Supplementation Pregnenolone is necessary for women of childbearing and reproductive age, overtime tracking pregnant women but there were fibroids from before pregnancy these fibroids will develop very quickly to stun the fetus many problems in pregnancy, and childbirth, the risk of miscarriage, preterm delivery,...The new drug will maintain a sufficient amount of Pregnenolone natural is the essence from Dioscorea persimilis prain \& burkill and associated with a necessary element is Coenzyme Pyridoxal Phosphate, Dydrogesterone. Compound presence in the body will curb the development of the muscle fibers uterus, the muscle fibers in the fibroids will soften, spread out, and disappear fibroids. The uterus returns to its normal state, the fetus will develop naturally.
Research results
- After 40 weeks of ultrasound examination:
- 100% of women using SB-UF drugs have the disappearance of fibroids, only the image of uterine muscle is thicker than usual.
- 100% of women who received SB-UF placebo did not experience any beneficial progress.
- Through study completion, an average of 40 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Selection of women ages 18 to 40, with pregnancy uterine fibroids and pregnancy in the 8th week of pregnancy.
| Arm | Type | Receives |
|---|---|---|
| SB-UF Drug | Experimental | Drug: SB-UFUse SB-UF drugs to lose the size of Uterine Fibroids on Women the Pregnancy. Measuring the size of uterine fibroid. Monitor the disappearance of uterine fibroids from 4 - 40 weeks |
| SB-UF Placebo | Placebo comparator | Device: SB-UF PlaceboUse SB-UF placebo to lose the size of Uterine Fibroids on Women the Pregnancy. Measuring the size of uterine fibroid. Monitor the disappearance of uterine fibroids from 4 - 40 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Procedure to the treatment of fibroids in pregnancy and in women desiring future fertility.
Key exclusion criteria (1 listed)
- Subserosal fibroids may be pedunculated hanging from a stalk inside or outside the uterus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB-UFAlso: Pregnenolone 60mg & Pyridoxal Phosphate 20mg & Dydrogesterone 10mg & Impatien balsamina extract 100 mgDosage: -Take 1tablet/2 times/day/in throughout pregnancy. | Drug | SB-UF Drug |
| SB-UF PlaceboAlso: Pregnenolone & Pyridoxal Phosphate PlaceboDosage: -Take 1tablet/2 times/day/in throughout pregnancy. | Device | SB-UF Placebo |
Primary outcome
Use SB-UF drugs to lose the size of Uterine Fibroids on Women the Pregnancy.
Time frame: 40 weeks
Measuring the size of uterine fibroid. Monitor the disappearance of benign smooth muscle cell tumors of the uterus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Contemporary Management of Fibroids in PregnancyLink provided by the sponsor.
- WO2020095085 - COMPOSITION for TREATING UTERINE FIBROIDSLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thi Trieu Nguyen, Dr. principal investigator
Trieu, Nguyen Thi, M.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SB-UF in people with Uterine Fibroids Affecting Pregnancy, run by Trieu, Nguyen Thi, M.D. at 1 site in Vietnam.
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 1 inclusion and 1 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 8 Jun 2026. 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 Vietnam. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Use SB-UF drugs to lose the size of Uterine Fibroids on Women the Pregnancy. (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.