NCT04694677

Brief Summary

Uterine leiomyomas (fibroids) are the most common benign tumors among women . Fibroids are found in approximately 15% to 30% of women in the reproductive age group

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

January 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

January 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

January 2, 2021

Last Update Submit

January 2, 2021

Conditions

Myoma

Outcome Measures

Primary Outcomes (1)

  • the number of women who will have less blood loss

    how many women will have less blood loss

    48 hours

Study Arms (2)

women receiving tranexamic acid

ACTIVE COMPARATOR
Drug: women receiving tranexamic acid

women receiving misoprostol

ACTIVE COMPARATOR
Drug: women receiving misoprostol

Interventions

women receiving tranexamic acidDRUG

women receiving tranexamic acid during myomectomy

women receiving tranexamic acid
women receiving misoprostolDRUG

women receiving misoprostol in myomectomy

women receiving misoprostol

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with myomas
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women with myomas

You may not qualify if:

  • with with malignant lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

Location

MeSH Terms

Conditions

Myoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Mahmoud Alalfy

    Algezeera hospitaland National Research Centre ,Egypt

    STUDY DIRECTOR

Central Study Contacts

Mahmoud Alalfy

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2021

First Posted

January 5, 2021

Study Start

January 10, 2021

Primary Completion

August 15, 2021

Study Completion

September 10, 2021

Last Updated

January 5, 2021

Record last verified: 2021-01

Locations

EG(1)