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Clinical Trials/NCT04762316
NCT04762316CompletedPhase 4

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.

Trieu, Nguyen Thi, M.D.4 sites in 2 countries66 target enrollmentStarted: January 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
66
Locations
4
Primary Endpoint
Use SB-UF drugs to lose the size of Uterine Fibroids on Women the Pregnancy.

Study Overview

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.

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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

Intervention: SB-UF (Drug)

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

Intervention: SB-UF Placebo (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Trieu, Nguyen Thi, M.D.
Sponsor Class
Indiv
Responsible Party
Sponsor

Study Sites (4)

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