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Composition for Treating Uterine Fibroid (PP6) (PP6)

Primary Purpose

Uterine Fibroids Affecting Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
PP6
PP6 Placebo
Sponsored by
Trieu, Nguyen Thi, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids Affecting Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Saigon Biopharma Company Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PP6 Drug

PP6 Placebo

Arm Description

Use PP6 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

Use PP6 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

Outcomes

Primary Outcome Measures

Use PP6 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

Secondary Outcome Measures

Full Information

First Posted
January 3, 2021
Last Updated
May 21, 2022
Sponsor
Trieu, Nguyen Thi, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT04762316
Brief Title
Composition for Treating Uterine Fibroid (PP6)
Acronym
PP6
Official Title
Uterine Fibroids Are a Very Common Finding in Women of Reproductive Age. Ready Safety Study Extracts of Plants Pregnenolone & Pyridoxal Phosphate for Treating Uterine Fibroids in Women of Reproductive Age and Women Pregnancy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trieu, Nguyen Thi, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pregnenolone & Pyridoxal Phosphate (PP6) for treating uterine fibroids in women pregnancy to lost the size 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 pregnancy. PP6 against the rapid growth of fibroids under the influence of hormones during pregnancy. Use to PP6 think about regulating stable Oestrogen level and to dissolve fibroids. This is a substantial insight into the pathogenesis of disease, with a clear path toward clinical application, or which would lead to a substantial advance and perfect 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 pregnancy. Clinically has shown that: Uterine fibroids are associated with heavy or prolonged menstrual periods, 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 a sufficient Pregnenolone and combined with Coenzyme Pyridoxal Phosphate, 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, 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. Compound presence in the body will curb the development exceed 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 PP6 drug have the disappearance of fibroids, only the image of uterine muscle is thicker than usual. 100% of women who received PP6 placebo did not experience any beneficial progress. Through study completion, an average of 40 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids Affecting Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Selection of women ages 18 to 40, with pregnancy uterine fibroids and pregnancy in the 8th week of pregnancy.
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PP6 Drug
Arm Type
Experimental
Arm Description
Use PP6 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
Arm Title
PP6 Placebo
Arm Type
Placebo Comparator
Arm Description
Use PP6 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 Type
Drug
Intervention Name(s)
PP6
Other Intervention Name(s)
Pregnenolone 40mg & Pyridoxal Phosphate 6mg
Intervention Description
Dosage: -Take 1tablet/2 times/day/in throughout pregnancy.
Intervention Type
Device
Intervention Name(s)
PP6 Placebo
Other Intervention Name(s)
Pregnenolone & Pyridoxal Phosphate Placebo
Intervention Description
Dosage: -Take 1tablet/2 times/day/in throughout pregnancy.
Primary Outcome Measure Information:
Title
Use PP6 drugs to lose the size of Uterine Fibroids on Women the Pregnancy.
Description
Measuring the size of uterine fibroid. Monitor the disappearance of benign smooth muscle cell tumors of the uterus
Time Frame
40 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women aged 18 to 40 years who are pregnant and have uterine fibroids in the following forms: Intramural fibroids, Submucosal fibroids, Subserous fibroids.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thi Trieu Nguyen, Dr.
Organizational Affiliation
Trieu, Nguyen Thi, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saigon Biopharma Company Limited
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2876319
Description
Contemporary Management of Fibroids in Pregnancy
URL
http://www.mayoclinic.org/diseases-conditions/uterine-fibroids/symptoms-causes/syc-20354288
Description
Uterine fibroids
URL
http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2020095085&_cid=P20-KJGXFA-35465-1
Description
WO2020095085 - COMPOSITION for TREATING UTERINE FIBROIDS

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Composition for Treating Uterine Fibroid (PP6)

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