NCT05203562

Brief Summary

Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of Gestational Trophoblastic Neoplasia (GTN) in patients with complete hydatidiform mole (CHM)

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 phase_2

Timeline
Completed

Started Jun 2020

Typical duration for phase_2

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

June 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

2.5 years

First QC Date

January 19, 2022

Last Update Submit

July 11, 2022

Conditions

Gestational Trophoblastic Disease

Keywords

Aromatase Inhibitor; Letrozole; GTN; Complete Mole

Outcome Measures

Primary Outcomes (7)

  • (β-hCG) level

    A quantitative human chorionic gonadotropin

    at the first day of evacuation

  • (β-hCG) level

    A quantitative human chorionic gonadotropin

    one month after evacuation

  • (β-hCG) level

    A quantitative human chorionic gonadotropin

    two months after evacuation

  • (β-hCG) level

    A quantitative human chorionic gonadotropin

    three months after evacuation

  • (β-hCG) level

    A quantitative human chorionic gonadotropin

    four months after evacuation

  • (β-hCG) level

    A quantitative human chorionic gonadotropin

    Five months after evacuation

  • (β-hCG) level

    A quantitative human chorionic gonadotropin

    Six months after evacuation

Study Arms (2)

Control group I

ACTIVE COMPARATOR

Patients with complete mole treated by evacuation of using suction curettage followed by conservative follow up

Procedure: Suction evacuation

Prophylactic letrozole group II

EXPERIMENTAL

Patients with complete mole treated by evacuation of using suction curettage followed by 5mg daily letrozole for 10 days followed by conservative follow up

Procedure: Suction evacuationDrug: Letrozole tablets

Interventions

Suction evacuationPROCEDURE

both groups underwent complete mole evacuation using suction curettage.

Also known as: Evacuation of CHM using Suction curettage
Control group IProphylactic letrozole group II
Letrozole tabletsDRUG

Group II Patients received 5mg(2tablets 2.5gm) daily letrozole for 10 days after complete mole evacuation

Also known as: 5mg daily (2 tablets 2.5 gm)
Prophylactic letrozole group II

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients with complete hydatidiform mole
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women were diagnosed to have CHM by ultrasound and confirmed by histopathological examination

You may not qualify if:

  • Metastatic disease associated with HM at presentation, in which situation chemotherapy, rather than prophylactic treatment, as prescribed,
  • Late diagnosis of CHM made only by histological examination of curetted material
  • Uterine evacuation at another hospital and patient seen at the optimum patient care only for follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed ALI Alabiad

Zagazig, Sharqia Province, 14150, Egypt

Location

MeSH Terms

Conditions

Gestational Trophoblastic DiseaseHydatidiform Mole

Interventions

Vacuum CurettageLetrozole

Condition Hierarchy (Ancestors)

Trophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsPregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Dilatation and CurettageCurettageSurgical Procedures, OperativeGynecologic Surgical ProceduresUrogenital Surgical ProceduresNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mohamed A Alabiad, MD

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2022

First Posted

January 24, 2022

Study Start

June 1, 2020

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

July 12, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

3 months after final complete

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
3 months after final complete
Access Criteria
Contac dr Mohamed at drno99@yahoo.com
More information

Locations

EG(1)