FibroidsPhase 4FibroidsNCT02620345
Fibroids in Women of Reproductive Age and Women Pregnancy
A Phase 4 study testing Dydrogesterone M ( case 1 ) and Dydrogesterone M ( case 2 ) in people with Fibroids, run by Trieu, Nguyen Thi, M.D..
Trial summary
Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and women pregnancy to lost the size fibroids. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibroids
- What is being tested?
- Dydrogesterone M ( case 1 ) and Dydrogesterone M ( case 2 )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Procedure to treatment of fibroids in pregnancy and in women desiring future fertility.
Who cannot join
- 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
About this study
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
Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and women pregnancy to lost the size fibroids.
Read the 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.
- Conditions
- Fibroids
- Being tested
- Dydrogesterone M ( case 1 ), Dydrogesterone M ( case 2 )
- Keywords
- Fibroids
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dydrogesterone M ( case 1 )Drug
Also called Dydrogesterone M
Dydrogesterone Multivitamin nature
- Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature.
- 1tablet/24 hours/day (to 4 weeks after postpartum)
Dydrogesterone M ( case 2 )Drug
Also called Dydrogesterone M
Dydrogesterone Multivitamin nature
- Fibroids/ Women of Reproductive age ( discovered fibroids )
- 1tablet/24 hours/day ( from discovered fibroids through 6 months)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dydrogesterone M ( case 2 ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from 4 weeks to 20 weeks
Secondary outcomes (1)
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.
Measured: from 20 weeks to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2010
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Responsible party
- Principal investigator, Triệu, Nguyễn Thị, M.D., Trieu, Nguyen Thi, M.D.
- Investigators
- Nguyen Thi Trieu, Master, Study director, Tran Minh Duc, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620345
- Sponsor's protocol ID
- Dydrogesterone Multivitamin
- Acronym
- Fibroids
- Status last verified
- Nov 2015
- First submitted
- 14 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02620345
- Acronym / sponsor ID
- Fibroids / Dydrogesterone Multivitamin
- Conditions
- Fibroids
- Keywords
- Fibroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Study start
- Jan 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and women pregnancy to lost the size fibroids.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dydrogesterone M/ Women Pregnancy | Experimental | Drug: Dydrogesterone M ( case 1 )* 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. |
| Dydrogesterone M/ Reproductive Age | Experimental | Drug: Dydrogesterone M ( case 2 )* 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Procedure to treatment of fibroids in pregnancy and in women desiring future fertility.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dydrogesterone M ( case 1 )Also: Dydrogesterone MDydrogesterone Multivitamin nature * Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature. * 1tablet/24 hours/day (to 4 weeks after postpartum) | Drug | Dydrogesterone M/ Women Pregnancy |
| Dydrogesterone M ( case 2 )Also: Dydrogesterone MDydrogesterone Multivitamin nature * Fibroids/ Women of Reproductive age ( discovered fibroids ) * 1tablet/24 hours/day ( from discovered fibroids through 6 months) | Drug | Dydrogesterone M/ Reproductive Age |
Primary outcome
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.
1 secondary outcome
Measure of fibroid size in millimeters
Time frame: from 20 weeks to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Contemporary Management of Fibroids in PregnancyLink provided by the sponsor.
- What is the treatment for uterine fibroids?Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nguyen Thi Trieu, Master study director
Tran Minh Duc, Dr.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dydrogesterone M ( case 1 ) and Dydrogesterone M ( case 2 ) in people with Fibroids, run by Trieu, Nguyen Thi, M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of fibroid size in millimeters (time frame: from 4 weeks to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.