NCT03841916

Brief Summary

Postmenopausal Bleeding (PMB) is defined as recurrent attacks of bleeding occurring in women after menopause one year at least after stoppage of cycles \[

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 P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

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

Study Start

First participant enrolled

December 2, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

February 12, 2019

Last Update Submit

March 8, 2019

Conditions

Postmenopausal Bleeding

Outcome Measures

Primary Outcomes (1)

  • the number of women who will have a relation between endometrial thickness and BMI

    if there is a relation between increased BMI and endometrial thickness

    within 2 weeks

Interventions

transvaginal ultrasoundDIAGNOSTIC_TEST

transvaginal ultrasound to measure endometrial thickness

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who have postmenopausal bleeding
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women with postmenopausal bleeding

You may qualify if:

  • menopausal women (defined as minimum of 1 year of amenorrhea after the age of 45 years if only the amenorrhea is not related to pregnancy, medication or disease),

You may not qualify if:

  • Women with chronic diseases as diabetes mellitus, hypertension or hematological disorders, those received hormone replacement therapy, Tamoxifen or anticoagulant therapy and women with adnexal massed detected by TVUS or apparent causes of bleeding from cervix or vagina e.g. ulcer were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah and Kasralainy hospital

Giza, Egypt

RECRUITING

Study Officials

  • Mahmoud Alalfy, PhD

    Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Alalfy, PhD

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 15, 2019

Study Start

December 2, 2018

Primary Completion

March 6, 2019

Study Completion

March 20, 2019

Last Updated

March 11, 2019

Record last verified: 2019-03

Locations

EG(1)