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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03841916
Other study ID # Body mass index
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2, 2018
Est. completion date March 20, 2019

Study information

Verified date March 2019
Source Aljazeera Hospital
Contact Mahmoud Alalfy, PhD
Phone 01002611058
Email mahmoudalalfy@ymail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

Premalignant lesions and malignant lesions most commonly complex hyperplasia with atypia and carcinoma of the endometrium are present in 1/3 of patients evaluated for postmenopausal bleed-ing, and so investigations for cases of postmeno-pausal bleeding are mandatory


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 20, 2019
Est. primary completion date March 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria:

- 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),

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
transvaginal ultrasound
transvaginal ultrasound to measure endometrial thickness

Locations

Country Name City State
Egypt Algazeerah and Kasralainy hospital Giza

Sponsors (2)

Lead Sponsor Collaborator
Aljazeera Hospital Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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