Intra-uterine Device ComplicationPhase 3NCT05971680
the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.
A Phase 3 study testing VITAMIN B1 500mg and intra-uterine contraceptive device in people with Intra-uterine Device Complication, run by Beni-Suef University at 1 site in Egypt.
Trial summary
investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intra-uterine Device Complication
- What is being tested?
- VITAMIN B1 500mg and intra-uterine contraceptive device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2023to 30 Nov 2023
- Phase
- Phase 3
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with first time use of the IUD
- a history of normal menstrual bleeding with duration of 3 to 7 days without spotting, a menstrual cycle lasting 23 to 35 days,
- use of 10 to 14 sanitary pads per cycle before IUD insertion
- gravidity ranging between 1 and 4.
Who cannot join
- Patients with cardiac, hepatic or renal diseases.
- Patients with bleeding disorders.
- Patients with systemic diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD.
Read the detailed description
This study will be randomized controlled trial will be performed at the Obstetric and Gynecological Department at Beni-Suef University Hospital, Faculty of Medicine Target Population: All females with first time use of IUD inserted at the Obstetrics and Gynecology department through 3 months from the start of July 2023 till the end of November 2023.
Participants will be assigned in a 1:1 ratio to the use of vitamin B 1 or placebo, in accordance with a random table produced by an Excel program, with A being assigned to the intervention group and B to the control group. All women will sign a written informed consent prior to data collection.
Each woman within the intervention group will receive a packet containing 30 pills (vitamin B 1 or placebo), each month for three months.
- Conditions
- Intra-uterine Device Complication
- Being tested
- VITAMIN B1 500mg, intra-uterine contraceptive device
- Keywords
- Intra-uterine Device, Vitamin B 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITAMIN B1 500mgDrug
Also called VITAMIN B1 500mg @Biovea
VITAMIN B1 (High Potency) 500mg tab every day for 3 months
intra-uterine contraceptive deviceDevice
Also called silverline IUD
intra-uterine contraceptive device
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B 1 | Experimental | VITAMIN B1 (High Potency) 500mg Receives: Drug: VITAMIN B1 500mg; Device: intra-uterine contraceptive device |
| control | Other | patient not subjected to treatment . only follow up Receives: Device: intra-uterine contraceptive device |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of menstrual bleeding.
days of menstruation
Measured: 3 cycles ( 3 months / one month for each cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-uterine Device ComplicationStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971680
- Sponsor's protocol ID
- Vitamin B 1 IUD
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.
- ClinicalTrials.gov ID
- NCT05971680
- Acronym / sponsor ID
- Vitamin B 1 IUD
- Conditions
- Intra-uterine Device Complication
- Keywords
- Intra-uterine Device, Vitamin B 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 2 Aug 2023 (actual)
- 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.
investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD.
Detailed description
This study will be randomized controlled trial will be performed at the Obstetric and Gynecological Department at Beni-Suef University Hospital, Faculty of Medicine Target Population: All females with first time use of IUD inserted at the Obstetrics and Gynecology department through 3 months from the start of July 2023 till the end of November 2023.
Participants will be assigned in a 1:1 ratio to the use of vitamin B 1 or placebo, in accordance with a random table produced by an Excel program, with A being assigned to the intervention group and B to the control group. All women will sign a written informed consent prior to data collection.
Each woman within the intervention group will receive a packet containing 30 pills (vitamin B 1 or placebo), each month for three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin B 1 | Experimental | Drug: VITAMIN B1 500mg, Device: intra-uterine contraceptive deviceVITAMIN B1 (High Potency) 500mg |
| control | Other | Device: intra-uterine contraceptive devicepatient not subjected to treatment . only follow up |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females with first time use of the IUD
- a history of normal menstrual bleeding with duration of 3 to 7 days without spotting, a menstrual cycle lasting 23 to 35 days,
- use of 10 to 14 sanitary pads per cycle before IUD insertion
- gravidity ranging between 1 and 4.
Key exclusion criteria (3 listed)
- Patients with cardiac, hepatic or renal diseases.
- Patients with bleeding disorders.
- Patients with systemic diseases.
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 |
|---|---|---|
| VITAMIN B1 500mgAlso: VITAMIN B1 500mg @BioveaVITAMIN B1 (High Potency) 500mg tab every day for 3 months | Drug | Vitamin B 1 |
| intra-uterine contraceptive deviceAlso: silverline IUDintra-uterine contraceptive device | Device | Vitamin B 1, control |
Primary outcome
the duration of menstrual bleeding.
Time frame: 3 cycles ( 3 months / one month for each cycle)
days of menstruation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VITAMIN B1 500mg and intra-uterine contraceptive device in people with Intra-uterine Device Complication, run by Beni-Suef University at 1 site in Egypt.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beni-suef University (082 2318605 ext. 02, fom@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration of menstrual bleeding. (time frame: 3 cycles ( 3 months / one month for each cycle)). 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 2 Aug 2023.