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Fibroids in Women of Reproductive Age and Women Pregnancy (Fibroids)

Primary Purpose

Fibroids

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dydrogesterone M ( case 1 )
Dydrogesterone M ( case 2 )
Sponsored by
Trieu, Nguyen Thi, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibroids focused on measuring Fibroids

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Whether or not you are having symptoms from the fibroids
  • If you might want to become pregnant in the future
  • The size of the fibroids
  • The location of the fibroids
  • Your age and you might be

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Dydrogesterone M/ Women Pregnancy

    Dydrogesterone M/ Reproductive Age

    Arm Description

    Reducing the size of fibroids with medication Drug: Dydrogesterone M 15mg/Fibroids/Women Pregnancy Dosage: 1tablet/24 hours/day/ (when seeing fibroids to 4 weeks after postpartum). Dydrogesterone 15mg/day Beta Carotene 4000 IU/day Ascorbic Acid 100 mg/day Cholecalciferol 400 IU/day Dl-Alpha Tocopheryl Acetate 11IU Thiamin Mononitrate 1.5 mg/day Riboflavin 1.7 mg/day Niacinamide 18 mg/day Pyridoxine Hydrochloride 2.6 mg/day Folic Acid 400 mcg/day Cyanocobalamin 4mcg/day Calcium Carbonate 150 mg/day Ferrous Fumarate 27 mg/day Zinc Oxide 25 mg/day The lost in size of fibroids throughout pregnancy after 48 weeks.

    Reducing the size of fibroids with medication Drug: Dydrogesterone M 15mg/Fibroids/Reproductive Age Dosage: 1tablet/24 hours/day/24 weeks ( from discovered fibroids through 24 weeks). Dydrogesterone 15mg/day Beta Carotene 4000 IU/day Ascorbic Acid 100 mg/day Cholecalciferol 400 IU/day Dl-Alpha Tocopheryl Acetate 11IU Thiamin Mononitrate 1.5 mg/day Riboflavin 1.7 mg/day Niacinamide 18 mg/day Pyridoxine Hydrochloride 2.6 mg/day Folic Acid 400 mcg/day Cyanocobalamin 4mcg/day Calcium Carbonate 150 mg/day Ferrous Fumarate 27 mg/day Zinc Oxide 25 mg/day The lost in size of fibroids after 24 weeks.

    Outcomes

    Primary Outcome Measures

    Measure of fibroid size in millimeters
    Patients fulfilling inclusion and exclusion criteria. Measure to have Fibroids size > 50mm x 60mm. Will be divided into two groups Group (A): Women Pregnancy. Measure of fibroid size in millimeters < 50mm x 60mm. Group (B): Women Reproductive age. Measure of fibroid size in millimeters < 50mm x 60mm.

    Secondary Outcome Measures

    Measure of fibroid size in millimeters
    Group (A):Women Pregnancy. - Measure of fibroid size in millimeters to loss the fibroids. Group (B): Women Reproductive age - Measure of fibroid size in millimeters to loss the fibroids.

    Full Information

    First Posted
    November 14, 2015
    Last Updated
    November 30, 2015
    Sponsor
    Trieu, Nguyen Thi, M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02620345
    Brief Title
    Fibroids in Women of Reproductive Age and Women Pregnancy
    Acronym
    Fibroids
    Official Title
    Uterine Fibroids Are a Very Common Finding in Women of Reproductive Age. Ready Safety Study Dydrogesterone + Multivitamin Nature in Women of Reproductive Age and Women Pregnancy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and women pregnancy to lost the size fibroids.
    Detailed Description
    Uterine fibroids are a very common finding in women of reproductive age. But may fibroids grow in the first trimester pregnancy. Clinically has shown that: Uterine fibroids are associated with an Heavy or prolonged menstrual periods. Abnormal bleeding between menstrual periods. Uterine fibroids are associated with an increased rate of spontaneous miscarriage, preterm labor, placenta abruption, malpresentation, labor dystocia, cesarean delivery, and postpartum hemorrhage, pain is the most common complication of fibroids during pregnancy. Can usually be controlled by conservative treatment on Dydrogesterone Multivitamin nature.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibroids
    Keywords
    Fibroids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dydrogesterone M/ Women Pregnancy
    Arm Type
    Experimental
    Arm Description
    Reducing the size of fibroids with medication Drug: Dydrogesterone M 15mg/Fibroids/Women Pregnancy Dosage: 1tablet/24 hours/day/ (when seeing fibroids to 4 weeks after postpartum). Dydrogesterone 15mg/day Beta Carotene 4000 IU/day Ascorbic Acid 100 mg/day Cholecalciferol 400 IU/day Dl-Alpha Tocopheryl Acetate 11IU Thiamin Mononitrate 1.5 mg/day Riboflavin 1.7 mg/day Niacinamide 18 mg/day Pyridoxine Hydrochloride 2.6 mg/day Folic Acid 400 mcg/day Cyanocobalamin 4mcg/day Calcium Carbonate 150 mg/day Ferrous Fumarate 27 mg/day Zinc Oxide 25 mg/day The lost in size of fibroids throughout pregnancy after 48 weeks.
    Arm Title
    Dydrogesterone M/ Reproductive Age
    Arm Type
    Experimental
    Arm Description
    Reducing the size of fibroids with medication Drug: Dydrogesterone M 15mg/Fibroids/Reproductive Age Dosage: 1tablet/24 hours/day/24 weeks ( from discovered fibroids through 24 weeks). Dydrogesterone 15mg/day Beta Carotene 4000 IU/day Ascorbic Acid 100 mg/day Cholecalciferol 400 IU/day Dl-Alpha Tocopheryl Acetate 11IU Thiamin Mononitrate 1.5 mg/day Riboflavin 1.7 mg/day Niacinamide 18 mg/day Pyridoxine Hydrochloride 2.6 mg/day Folic Acid 400 mcg/day Cyanocobalamin 4mcg/day Calcium Carbonate 150 mg/day Ferrous Fumarate 27 mg/day Zinc Oxide 25 mg/day The lost in size of fibroids after 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Dydrogesterone M ( case 1 )
    Other Intervention Name(s)
    Dydrogesterone M
    Intervention Description
    Dydrogesterone Multivitamin nature Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature. 1tablet/24 hours/day (to 4 weeks after postpartum)
    Intervention Type
    Drug
    Intervention Name(s)
    Dydrogesterone M ( case 2 )
    Other Intervention Name(s)
    Dydrogesterone M
    Intervention Description
    Dydrogesterone Multivitamin nature Fibroids/ Women of Reproductive age ( discovered fibroids ) 1tablet/24 hours/day ( from discovered fibroids through 6 months)
    Primary Outcome Measure Information:
    Title
    Measure of fibroid size in millimeters
    Description
    Patients fulfilling inclusion and exclusion criteria. Measure to have Fibroids size > 50mm x 60mm. Will be divided into two groups Group (A): Women Pregnancy. Measure of fibroid size in millimeters < 50mm x 60mm. Group (B): Women Reproductive age. Measure of fibroid size in millimeters < 50mm x 60mm.
    Time Frame
    from 4 weeks to 20 weeks
    Secondary Outcome Measure Information:
    Title
    Measure of fibroid size in millimeters
    Description
    Group (A):Women Pregnancy. - Measure of fibroid size in millimeters to loss the fibroids. Group (B): Women Reproductive age - Measure of fibroid size in millimeters to loss the fibroids.
    Time Frame
    from 20 weeks to 48 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Procedure to treatment of fibroids in pregnancy and in women desiring future fertility. Exclusion Criteria: Whether or not you are having symptoms from the fibroids If you might want to become pregnant in the future The size of the fibroids The location of the fibroids Your age and you might be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nguyen Thi Trieu, Master
    Organizational Affiliation
    Tran Minh Duc, Dr.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.ncbi.nlm.nih.gov
    Description
    Contemporary Management of Fibroids in Pregnancy
    URL
    http://www.medicinenet.com
    Description
    What is the treatment for uterine fibroids?

    Learn more about this trial

    Fibroids in Women of Reproductive Age and Women Pregnancy

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