Composition for Treating Uterine Fibroid (SB-UF)

NCT04762316 | Completed Phase 4 FDA Drug

• 1 other identifier: Removal the Uterine Fibroids
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Uterine Fibroids Affecting Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

  40 weeks

Study Arms (2)

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

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

Device: SB-UF Placebo

Interventions

SB-UF DRUG

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

Also known as: Pregnenolone 60mg & Pyridoxal Phosphate 20mg & Dydrogesterone 10mg & Impatien balsamina extract 100 mg

SB-UF Drug

SB-UF Placebo DEVICE

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

Also known as: Pregnenolone & Pyridoxal Phosphate Placebo

SB-UF Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women aged 18 to 40 years who are pregnant and have uterine fibroids in the following forms: Intramural fibroids, Submucosal fibroids, Subserous fibroids.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Procedure to the treatment of fibroids in pregnancy and in women desiring future fertility.

You may not qualify if:

• Subserosal fibroids may be pedunculated hanging from a stalk inside or outside the uterus.

Sponsors & Collaborators

• Trieu, Nguyen Thi, M.D.: lead
• TRAN MINH DUC, MD: collaborator

Study Sites (2)

Saigon Biopharma LLC

Wilmington, Delaware, 19801-6601, United States

Location

Saigon Biopharma Company Limited

Ho Chi Minh City, 700000, Vietnam

Location

Related Links

• Contemporary Management of Fibroids in Pregnancy
• Uterine fibroids
• WO2020095085 - COMPOSITION for TREATING UTERINE FIBROIDS

MeSH Terms

Interventions

Pregnenolone; Pyridoxal Phosphate; Dydrogesterone

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Pyridoxal; Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Pregnadienes

Study Officials

• Thi Trieu Nguyen, Dr.

  Trieu, Nguyen Thi, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The number of post-recruiting people who have fibroids is divided into 2 groups * The group of pregnancy uterine fibroids uses drugs under study. * The group of pregnancy uterine fibroids uses a placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: Selection of women ages 18 to 40, with pregnancy uterine fibroids and pregnancy in the 8th week of pregnancy.

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: February 21, 2021
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); VN (1)