NCT05971680

Brief Summary

investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 25, 2023

Last Update Submit

July 25, 2023

Conditions

Intra-uterine Device Complication

Keywords

Intra-uterine DeviceVitamin B 1

Outcome Measures

Primary Outcomes (1)

  • the duration of menstrual bleeding.

    days of menstruation

    3 cycles ( 3 months / one month for each cycle)

Study Arms (2)

Vitamin B 1

EXPERIMENTAL

VITAMIN B1 (High Potency) 500mg

Drug: VITAMIN B1 500mgDevice: intra-uterine contraceptive device

control

OTHER

patient not subjected to treatment . only follow up

Device: intra-uterine contraceptive device

Interventions

VITAMIN B1 500mgDRUG

VITAMIN B1 (High Potency) 500mg tab every day for 3 months

Also known as: VITAMIN B1 500mg @Biovea
Vitamin B 1
intra-uterine contraceptive deviceDEVICE

intra-uterine contraceptive device

Also known as: silverline IUD
Vitamin B 1control

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with cardiac, hepatic or renal diseases.
  • Patients with bleeding disorders.
  • Patients with systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Interventions

ThiamineIntrauterine Devices

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesContraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Central Study Contacts

Beni-suef University

CONTACT

082 2318605fom@med.bsu.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

July 30, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Locations

EG(1)