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

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: Fibroids
• Intervention / Treatment: Drug: Dydrogesterone M ( case 1 ); Drug: Dydrogesterone M ( case 2 )

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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/dayThe 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/dayThe 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	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	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

• Sponsor: Trieu, Nguyen Thi, M.D.
• Investigators: Study Director: Nguyen Thi Trieu, Master, Tran Minh Duc, Dr.

Publications and helpful links

Helpful Links

• Contemporary Management of Fibroids in Pregnancy
• What is the treatment for uterine fibroids?

Study record dates

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: Fibroids
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Dydrogesterone
• Other Study ID Numbers: Dydrogesterone Multivitamin