NCT07707570

Brief Summary

To evaluate hysteroscopic findings in women with postmenopausal bleeding and correlate them with histopathological results of the endometrium., Sohag University Hospital Obstetrics and Gynecology department

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 11, 2026

Last Update Submit

July 11, 2026

Conditions

Keywords

postmenopausal

Outcome Measures

Primary Outcomes (1)

  • evaluate hysteroscopic findings in women with postmenopausal bleeding and correlate them with histopathological results of the endometrium

    All patients in this study will be subjected to the following (as detailed in the attached patient's data sheet). I. Clinical Assessment * Detailed history including: * Duration since menopause * Pattern and duration of bleeding * Obstetric and medical history * General abdominal and pelvic examination II. Transvaginal Ultrasound (TVS) * Measurement of endometrial thickness * Assessment of uterine and adnexal pathology III. Hysteroscopic Examination Hysteroscopy will be performed using a rigid hysteroscope to evaluate: * Endometrial appearance * Presence of polyps, hyperplasia, or malignancy Hysteroscopic findings will be classified as: * Normal (proliferative, secretory, atrophic) * Abnormal (polyp, hyperplasia, carcinoma, fibroid) (1,3) Criteria suggestive of: * Hyperplasia: irregular thickened endometrium, increased vascularity (1,3) * Carcinoma: irregular necrotic tissue, atypical vessels, friable surface (1,3) IV. Endometrial Sampling • Directed biopsy will be taken from s

    2 weeks

Study Arms (1)

Postmenopausal bleeding patients

* Postmenopausal women presenting with uterine bleeding * Age ≥ 45 years

Eligibility Criteria

Age45 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in this study will be subjected to the following (as detailed in the attached patient's data sheet). I. Clinical Assessment * Detailed history including: * Duration since menopause * Pattern and duration of bleeding * Obstetric and medical history * General abdominal and pelvic examination II. Transvaginal Ultrasound (TVS) * Measurement of endometrial thickness * Assessment of uterine and adnexal pathology III. Hysteroscopic Examination Hysteroscopy will be performed using a rigid hysteroscope to evaluate: * Endometrial appearance * Presence of polyps, hyperplasia, or malignancy Hysteroscopic findings will be classified as: * Normal (proliferative, secretory, atrophic) * Abnormal (polyp, hyperplasia, carcinoma, fibroid) (1,3) Criteria suggestive of: * Hyperplasia: irregular thickened endometrium, increased vascularity (1,3) * Carcinoma: irregular necrotic tissue, atypical vessels, friable surface (1,3) IV. Endometrial Sampling • Directed biopsy will be taken from su

You may qualify if:

  • Postmenopausal women presenting with uterine bleeding
  • Age ≥ 45 years

You may not qualify if:

  • Women on hormone replacement therapy
  • Bleeding due to vulvar, vaginal, cervical, or urethral causes
  • Patients on anticoagulant therapy
  • Patients unfit for hysteroscopy
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mahmoud Sabri Mahmoud Mohamed Sabri Mahmoud, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mahmoud Sabry Mahmoud Mohamed

Study Record Dates

First Submitted

July 11, 2026

First Posted

July 16, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07