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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02620345
First Posted: December 3, 2015
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Triệu, Nguyễn Thị, M.D.
  Purpose
Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and women pregnancy to lost the size fibroids.

Condition Intervention Phase
Fibroids Drug: Dydrogesterone M ( case 1 ) Drug: Dydrogesterone M ( case 2 ) Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Triệu, Nguyễn Thị, M.D.:

Primary Outcome Measures:
  • Measure of fibroid size in millimeters [ Time Frame: 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:
  • Measure of fibroid size in millimeters [ Time Frame: 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.



Enrollment: 22
Study Start Date: January 2010
Study Completion Date: November 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Dydrogesterone M

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620345


Sponsors and Collaborators
Triệu, Nguyễn Thị, M.D.
Investigators
Study Director: Nguyen Thi Trieu, Master Tran Minh Duc, Dr.
  More Information

Additional Information:
Responsible Party: Triệu, Nguyễn Thị, M.D., Clinical Study
ClinicalTrials.gov Identifier: NCT02620345     History of Changes
Other Study ID Numbers: Dydrogesterone Multivitamin
First Submitted: November 14, 2015
First Posted: December 3, 2015
Last Update Posted: December 3, 2015
Last Verified: November 2015

Keywords provided by Triệu, Nguyễn Thị, M.D.:
Fibroids

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Calcium Carbonate
Ferrous fumarate
Pyridoxine
Dydrogesterone
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Vitamin B Complex
Vitamins