Fibroids in Women of Reproductive Age and Women Pregnancy

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

Detailed Description
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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.

Official Title
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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

Conditions
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Fibroids

Intervention / Treatment
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* Drug: Dydrogesterone M ( case 1 )
* Drug: Dydrogesterone M ( case 2 )


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dydrogesterone M/ Women Pregnancy<br>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 )<br>* Dydrogesterone Multivitamin nature Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature. 1tablet/24 hours/day (to 4 weeks after postpartum)<br>* Other names: Dydrogesterone M;|
| Experimental: Dydrogesterone M/ Reproductive Age<br>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 )<br>* Dydrogesterone Multivitamin nature Fibroids/ Women of Reproductive age ( discovered fibroids ) 1tablet/24 hours/day ( from discovered fibroids through 6 months)<br>* Other names: Dydrogesterone M;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroids