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Completed

NCT Number: NCT04762316

Composition for Treating Uterine Fibroid (SB-UF)

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Saigon Biopharma Company Limited

Ho Chi Minh City, 700000, Vietnam

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-UF

Drug

Dosage:

-Take 1tablet/2 times/day/in throughout pregnancy.

Other names: Pregnenolone 60mg & Pyridoxal Phosphate 20mg & Dydrogesterone 10mg & Impatien balsamina extract 100 mg

SB-UF Placebo

Device

Dosage:

-Take 1tablet/2 times/day/in throughout pregnancy.

Other names: Pregnenolone & Pyridoxal Phosphate Placebo

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Trieu, Nguyen Thi, M.D.

Indiv

Registry information

Official study 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.

Acronym: SB-UF

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2021
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.