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Fibroids in Women of Reproductive Age and Women Pregnancy

Sponsor
Trieu, Nguyen Thi, M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT02620345
Collaborator
(none)
22
Enrollment
2
Arms
70
Duration (Months)

Study Details

Study Description

Brief Summary

Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and women pregnancy to lost the size fibroids.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dydrogesterone M ( case 1 )
  • Drug: Dydrogesterone M ( case 2 )
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dydrogesterone M/ Women Pregnancy

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.

Drug: Dydrogesterone M ( case 1 )
Dydrogesterone Multivitamin nature Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature. 1tablet/24 hours/day (to 4 weeks after postpartum)
Other Names:
  • Dydrogesterone M

    		•
    Experimental: Dydrogesterone M/ Reproductive Age

    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.

    Drug: Dydrogesterone M ( case 2 )
    Dydrogesterone Multivitamin nature Fibroids/ Women of Reproductive age ( discovered fibroids ) 1tablet/24 hours/day ( from discovered fibroids through 6 months)
    Other Names:
  • Dydrogesterone M

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measure of fibroid size in millimeters [from 4 weeks to 20 weeks]

      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

    1. Measure of fibroid size in millimeters [from 20 weeks to 48 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Trieu, Nguyen Thi, M.D.

    Investigators

    • Study Director: Nguyen Thi Trieu, Master, Tran Minh Duc, Dr.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Triệu, Nguyễn Thị, M.D., Clinical Study, Trieu, Nguyen Thi, M.D.
    ClinicalTrials.gov Identifier:
    NCT02620345
    Other Study ID Numbers:
    • Dydrogesterone Multivitamin
    First Posted:
    Dec 3, 2015
    Last Update Posted:
    Dec 3, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Triệu, Nguyễn Thị, M.D., Clinical Study, Trieu, Nguyen Thi, M.D.
    Fibroids
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Dydrogesterone

    Study Results

    No Results Posted as of Dec 3, 2015