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

November 30, 2015 updated by: Triệu, Nguyễn Thị, M.D., Trieu, Nguyen Thi, M.D.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from 4 weeks to 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from 20 weeks to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trieu, Nguyen Thi, M.D.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 14, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dydrogesterone Multivitamin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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