Gestational Trophoblastic DiseasePhase 2/3NCT05203562
Letrozole as a Prophylaxis From GTN for Complete Mole Patients
A Phase 2/3 study testing Suction evacuation and Letrozole tablets in people with Gestational Trophoblastic Disease, run by Zagazig University at 1 site in Egypt.
Trial summary
Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of Gestational Trophoblastic Neoplasia (GTN) in patients with complete hydatidiform mole (CHM) Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Gestational Trophoblastic Disease
- What is being tested?
- Suction evacuation and Letrozole tablets
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Jun 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women were diagnosed to have CHM by ultrasound and confirmed by histopathological examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prophylactic Role of Aromatase Inhibitor Letrozole in Decreasing the Incidence of Gestational Trophoblastic Neoplasia in Patients With Complete Hydatidiform Mole
Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of Gestational Trophoblastic Neoplasia (GTN) in patients with complete hydatidiform mole (CHM)
Read the detailed description
Management of hydatidiform mole is usually evacuation followed by β-hcg surveillance to early detect cases of GTN . The risk of developing GTN is reported to be 16% to 20% in women with CHM . GTN is a potentially life-threatening malignancy but has an excellent cure rate. Trials were conducted to assess the role of prophylactic chemotherapy to prevent the development of GTN. In addition to their side effects, a meta-analysis concluded that there is insufficient evidence to support the use of prophylactic chemotherapy in clinical practice. Third-generation aromatase inhibitors such as letrozole have been shown to successfully block estrogen production in women of reproductive age. Their safety, high tolerability, low cost, and associated minimal adverse effects have all been established over several decades of clinical use and recently used successfully alone in the medical treatment of ectopic pregnancy making marked degenerative effects on the placenta.
The study hypothesizes that by inhibiting the estrogen synthetase (the aromatase enzyme) progesterone would not exert its physiological role in maintaining early pregnancy including complete hydatidiform mole. Thus, using a prophylactic aromatase inhibitor after CHM may have a role in the prevention of GTN and more effective clearance of β-hcg.
Rational GTN is a potentially life-threatening malignancy. The risk of progression of CHM to GTN is 20%. Prophylactic use of aromatase inhibitor may decrease the incidence of GTN.
Research question:
Is prophylactic use of aromatase inhibitor effective in decreasing the incidence of GTN in patients with CHM
Hypothesis Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of GTN in patients with CHM
Aim of this work The study aims at figuring out whether prophylactic use of aromatase inhibitor is effective in decreasing the incidence of GTN in patients with CHM.
OBJECTIVES
- To assess the incidence of GTN after the evacuation of CHM without prophylactic use of aromatase inhibitor.
- To assess the incidence of GTN after the evacuation of CHM without prophylactic use of aromatase inhibitor.
- To assess the side effects of aromatase inhibitor when used as a prophylaxis against GTN development in CHM cases.
PATIENTS AND METHODS
Technical design:
- Setting: Department of Obstetrics and Gynecology
- Sample size: 200 patients diagnosed to have CHM by ultrasound and confirmed by histopathological examination.
Operational design:
- Type of the study: a randomized controlled trial.
- Steps of performance and techniques that will be used women included in the study will be subjected to the following
Preoperative
- Complete history taking.
- General and abdominal examination.
- Routine preoperative laboratory investigations.
- Ultrasound to diagnose complete hydatidiform mole.
- Measurement of β-hcg level. Intraoperative
- Evacuation of CHM using Suction curettage.
- Tissues obtained during an evacuation will be sent for histological assessment. Post-operative
- Women will be randomized classified into two groups
- Control group I: Conservative follow up
- Prophylactic letrozole group II 5-mg Letrozole will be administered as two 2.5-mg tablets every day for 10 days.
- All Patients will receive instruction to return for β-hcg follow up which will be done weekly till complete resolution then monthly for 6 months.
- Participants will be advised to receive contraception during the follow-up period.
- The patients who will develop GTN in either group will be picked up and the incidence of GTN will be calculated in each group.
- Conditions
- Gestational Trophoblastic Disease
- Being tested
- Suction evacuation, Letrozole tablets
- Keywords
- Aromatase Inhibitor; Letrozole; GTN; Complete Mole
- Medical subject headings
- Gestational Trophoblastic Disease, Hydatidiform Mole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction evacuationProcedure or surgery
Also called Evacuation of CHM using Suction curettage
both groups underwent complete mole evacuation using suction curettage.
Letrozole tabletsDrug
Also called 5mg daily (2 tablets 2.5 gm)
Group II Patients received 5mg(2tablets 2.5gm) daily letrozole for 10 days after complete mole evacuation
| Study group | Role | What they receive |
|---|---|---|
| Control group I | Active comparator | Patients with complete mole treated by evacuation of using suction curettage followed by conservative follow up Receives: 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 Receives: Procedure: Suction evacuation; Drug: Letrozole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
(β-hCG) level
A quantitative human chorionic gonadotropin
Measured: at the first day of evacuation
(β-hCG) level
A quantitative human chorionic gonadotropin
Measured: one month after evacuation
(β-hCG) level
A quantitative human chorionic gonadotropin
Measured: two months after evacuation
(β-hCG) level
A quantitative human chorionic gonadotropin
Measured: three months after evacuation
(β-hCG) level
A quantitative human chorionic gonadotropin
Measured: four months after evacuation
(β-hCG) level
A quantitative human chorionic gonadotropin
Measured: Five months after evacuation
(β-hCG) level
A quantitative human chorionic gonadotropin
Measured: Six months after evacuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jun 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Trophoblastic DiseaseStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Ali Alabiad, MD, Zagazig University
- Investigators
- Mohamed A Alabiad, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203562
- Sponsor's protocol ID
- LETROZOLE IN CHM
- Status last verified
- Jul 2022
- First submitted
- 19 Jan 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 3 months after final complete
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prophylactic Role of Aromatase Inhibitor Letrozole in Decreasing the Incidence of Gestational Trophoblastic Neoplasia in Patients With Complete Hydatidiform Mole
- ClinicalTrials.gov ID
- NCT05203562
- Acronym / sponsor ID
- LETROZOLE IN CHM
- Conditions
- Gestational Trophoblastic Disease
- Keywords
- Aromatase Inhibitor; Letrozole; GTN; Complete Mole
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of Gestational Trophoblastic Neoplasia (GTN) in patients with complete hydatidiform mole (CHM)
Detailed description
Management of hydatidiform mole is usually evacuation followed by β-hcg surveillance to early detect cases of GTN . The risk of developing GTN is reported to be 16% to 20% in women with CHM . GTN is a potentially life-threatening malignancy but has an excellent cure rate. Trials were conducted to assess the role of prophylactic chemotherapy to prevent the development of GTN. In addition to their side effects, a meta-analysis concluded that there is insufficient evidence to support the use of prophylactic chemotherapy in clinical practice. Third-generation aromatase inhibitors such as letrozole have been shown to successfully block estrogen production in women of reproductive age. Their safety, high tolerability, low cost, and associated minimal adverse effects have all been established over several decades of clinical use and recently used successfully alone in the medical treatment of ectopic pregnancy making marked degenerative effects on the placenta.
The study hypothesizes that by inhibiting the estrogen synthetase (the aromatase enzyme) progesterone would not exert its physiological role in maintaining early pregnancy including complete hydatidiform mole. Thus, using a prophylactic aromatase inhibitor after CHM may have a role in the prevention of GTN and more effective clearance of β-hcg.
Rational GTN is a potentially life-threatening malignancy. The risk of progression of CHM to GTN is 20%. Prophylactic use of aromatase inhibitor may decrease the incidence of GTN.
Research question:
Is prophylactic use of aromatase inhibitor effective in decreasing the incidence of GTN in patients with CHM
Hypothesis Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of GTN in patients with CHM
Aim of this work The study aims at figuring out whether prophylactic use of aromatase inhibitor is effective in decreasing the incidence of GTN in patients with CHM.
OBJECTIVES
- To assess the incidence of GTN after the evacuation of CHM without prophylactic use of aromatase inhibitor.
- To assess the incidence of GTN after the evacuation of CHM without prophylactic use of aromatase inhibitor.
- To assess the side effects of aromatase inhibitor when used as a prophylaxis against GTN development in CHM cases.
PATIENTS AND METHODS
Technical design:
- Setting: Department of Obstetrics and Gynecology
- Sample size: 200 patients diagnosed to have CHM by ultrasound and confirmed by histopathological examination.
Operational design:
- Type of the study: a randomized controlled trial.
- Steps of performance and techniques that will be used women included in the study will be subjected to the following
Preoperative
- Complete history taking.
- General and abdominal examination.
- Routine preoperative laboratory investigations.
- Ultrasound to diagnose complete hydatidiform mole.
- Measurement of β-hcg level. Intraoperative
- Evacuation of CHM using Suction curettage.
- Tissues obtained during an evacuation will be sent for histological assessment. Post-operative
- Women will be randomized classified into two groups
- Control group I: Conservative follow up
- Prophylactic letrozole group II 5-mg Letrozole will be administered as two 2.5-mg tablets every day for 10 days.
- All Patients will receive instruction to return for β-hcg follow up which will be done weekly till complete resolution then monthly for 6 months.
- Participants will be advised to receive contraception during the follow-up period.
- The patients who will develop GTN in either group will be picked up and the incidence of GTN will be calculated in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group I | Active comparator | Procedure: Suction evacuationPatients with complete mole treated by evacuation of using suction curettage followed by conservative follow up |
| Prophylactic letrozole group II | Experimental | Procedure: Suction evacuation, Drug: Letrozole tabletsPatients with complete mole treated by evacuation of using suction curettage followed by 5mg daily letrozole for 10 days followed by conservative follow up |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women were diagnosed to have CHM by ultrasound and confirmed by histopathological examination
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suction evacuationAlso: Evacuation of CHM using Suction curettageboth groups underwent complete mole evacuation using suction curettage. | Procedure or surgery | Control group I, Prophylactic letrozole group II |
| Letrozole tabletsAlso: 5mg daily (2 tablets 2.5 gm)Group II Patients received 5mg(2tablets 2.5gm) daily letrozole for 10 days after complete mole evacuation | Drug | Prophylactic letrozole group II |
Primary outcome
(β-hCG) level
Time frame: at the first day of evacuation
A quantitative human chorionic gonadotropin
(β-hCG) level
Time frame: one month after evacuation
A quantitative human chorionic gonadotropin
(β-hCG) level
Time frame: two months after evacuation
A quantitative human chorionic gonadotropin
(β-hCG) level
Time frame: three months after evacuation
A quantitative human chorionic gonadotropin
(β-hCG) level
Time frame: four months after evacuation
A quantitative human chorionic gonadotropin
(β-hCG) level
Time frame: Five months after evacuation
A quantitative human chorionic gonadotropin
(β-hCG) level
Time frame: Six months after evacuation
A quantitative human chorionic gonadotropin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: Yes. 3 months after final complete
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Alabiad, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Suction evacuation and Letrozole tablets in people with Gestational Trophoblastic Disease, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(β-hCG) level (time frame: at the first day of evacuation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.