NCT02620345

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
Last Updated

December 3, 2015

Status Verified

November 1, 2015

Enrollment Period

5.8 years

First QC Date

November 14, 2015

Last Update Submit

November 30, 2015

Conditions

Fibroids

Keywords

Fibroids

Outcome Measures

Primary Outcomes (1)

  • 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.

    from 4 weeks to 20 weeks

Secondary Outcomes (1)

  • Measure of fibroid size in millimeters

    from 20 weeks to 48 weeks

Study Arms (2)

Dydrogesterone M/ Women Pregnancy

EXPERIMENTAL

* 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 M/ Reproductive Age

EXPERIMENTAL

* 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 )

Interventions

Dydrogesterone M ( case 1 )DRUG

Dydrogesterone Multivitamin nature * Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature. * 1tablet/24 hours/day (to 4 weeks after postpartum)

Also known as: Dydrogesterone M
Dydrogesterone M/ Women Pregnancy
Dydrogesterone M ( case 2 )DRUG

Dydrogesterone Multivitamin nature * Fibroids/ Women of Reproductive age ( discovered fibroids ) * 1tablet/24 hours/day ( from discovered fibroids through 6 months)

Also known as: Dydrogesterone M
Dydrogesterone M/ Reproductive Age

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Nguyen Thi Trieu, Master

    Tran Minh Duc, Dr.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Study

Study Record Dates

First Submitted

November 14, 2015

First Posted

December 3, 2015

Study Start

January 1, 2010

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-11