Myoma;UterusPhase 4NCT04364581
Endometrial Preparation by Short Course of Letrozole Before Hysteroscopic Removal of Endocavitary Lesions
A Phase 4 study testing Letrozole in people with Myoma;Uterus, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effectiveness of short course of letrozole for endometrial preparation before hysteroscopic surgery for intracavitary lesions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Myoma;Uterus
- What is being tested?
- Letrozole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 May 2021
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with endouterine pathologies, identified by office diagnostic hysteroscopy during the early endometrial proliferative phase (cycle days 7 to 8)
Who cannot join
- Presence of large submucous (type I, type II) or endocavitary (type 0) fibroids (according to the European Society of Hysteroscopy Classification of Submucous Fibroids) with a diameter exceeding 4 cm, for which preoperative treatment with GnRH agonists is indicated.
- Hormonal therapies in the previous 8 weeks (including the drug of the study).
- Uterine and/or concomitant adnexal pathologies (including malignancy) for which hysteroscopic surgery was not considered either safe or the method to resolve the problem.
- Cardiovascular, hepatic, or renal impairment.
- Allergy to letrozole.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
About this study
The aim of this study is to evaluate the effectiveness of short course of letrozole for endometrial preparation before hysteroscopic surgery for intracavitary lesions.
Read the detailed description
In the cycle subsequent to hysteroscopic identification of an endouteine pathology, patients who fitted with the inclusion criteria will be randomly divided into two groups; letrozole group (study group) and placebo group (control group). The randomization will be a stratified randomization with permuted blocking (the block size is randomly permuted among 2, 4, and 6) within each stratum. The only stratification variable will be by type of endouterine pathology. The randomization will be balanced (using a 1:1 treatment ratio) and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing computer-generated random numbers. The study will be double-blind (the participants, caregivers and investigators will be blinded to block size and group assignment).
Women in the letrozole group will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention while women in the placebo group will be treated with placebo for 10 days before hysteroscopic intervention in the early follicular phase of a natural cycle. In both groups, monopolar hysteroscopic surgery with glycine (1.5%) as uterine distension media will be used. Precise records of the duration of each surgical procedure, from the insertion to the removal of the resectoscope will be done.
Measurements of inflow, outflow, and amount of distension liquid absorbed by the patient will be taken meticulously. Intraoperative bleeding will be defined as "light" when bleeding does not interfere with surgery, "moderate" when bleeding required the coagulation of vessels, and "severe" when hemorrhage required immediate suspension of hysteroscopy. At the end of surgery, surgeon satisfaction with endometrial preparation using Visual Analogue Scale (VAS) and quality of visualization of the uterine cavity will be compared. Postoperative complications will be defined as the appearance of any complications occurring from the termination of the surgery to discharge.
- Conditions
- Myoma;Uterus
- Being tested
- Letrozole, Placebo
- Keywords
- Letrozole, Submucous myoma
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
Women will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention
PlaceboDrug
Women will be treated with placebo for 10 days before hysteroscopic intervention
| Study group | Role | What they receive |
|---|---|---|
| Letrozole group | Active comparator | Women will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention Receives: Drug: Letrozole |
| Placebo group | Placebo comparator | Women will be treated with placebo for 10 days before hysteroscopic intervention Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Time from start to end of the procedure
Measured: Until 2 hours from the start of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myoma;UterusStudies of the same condition, open and under way.
- More trials run by Mansoura 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yomna Ayman, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, MD, Study director, Mansoura UniversityRafik I Barakat, MD, Study director, Mansoura UniversityTarek A Shokir, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364581
- Sponsor's protocol ID
- MS.19.06.685.R1.R2
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Preparation by Short Course of Letrozole Before Hysteroscopic Removal of Endocavitary Lesions
- ClinicalTrials.gov ID
- NCT04364581
- Acronym / sponsor ID
- MS.19.06.685.R1.R2
- Conditions
- Myoma;Uterus
- Keywords
- Letrozole, Submucous myoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 28 Apr 2020 (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.
The aim of this study is to evaluate the effectiveness of short course of letrozole for endometrial preparation before hysteroscopic surgery for intracavitary lesions.
Detailed description
In the cycle subsequent to hysteroscopic identification of an endouteine pathology, patients who fitted with the inclusion criteria will be randomly divided into two groups; letrozole group (study group) and placebo group (control group). The randomization will be a stratified randomization with permuted blocking (the block size is randomly permuted among 2, 4, and 6) within each stratum. The only stratification variable will be by type of endouterine pathology. The randomization will be balanced (using a 1:1 treatment ratio) and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing computer-generated random numbers. The study will be double-blind (the participants, caregivers and investigators will be blinded to block size and group assignment).
Women in the letrozole group will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention while women in the placebo group will be treated with placebo for 10 days before hysteroscopic intervention in the early follicular phase of a natural cycle. In both groups, monopolar hysteroscopic surgery with glycine (1.5%) as uterine distension media will be used. Precise records of the duration of each surgical procedure, from the insertion to the removal of the resectoscope will be done.
Measurements of inflow, outflow, and amount of distension liquid absorbed by the patient will be taken meticulously. Intraoperative bleeding will be defined as "light" when bleeding does not interfere with surgery, "moderate" when bleeding required the coagulation of vessels, and "severe" when hemorrhage required immediate suspension of hysteroscopy. At the end of surgery, surgeon satisfaction with endometrial preparation using Visual Analogue Scale (VAS) and quality of visualization of the uterine cavity will be compared. Postoperative complications will be defined as the appearance of any complications occurring from the termination of the surgery to discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole group | Active comparator | Drug: LetrozoleWomen will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention |
| Placebo group | Placebo comparator | Drug: PlaceboWomen will be treated with placebo for 10 days before hysteroscopic intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with endouterine pathologies, identified by office diagnostic hysteroscopy during the early endometrial proliferative phase (cycle days 7 to 8)
Key exclusion criteria (5 listed)
- Presence of large submucous (type I, type II) or endocavitary (type 0) fibroids (according to the European Society of Hysteroscopy Classification of Submucous Fibroids) with a diameter exceeding 4 cm, for which preoperative treatment with GnRH agonists is indicated.
- Hormonal therapies in the previous 8 weeks (including the drug of the study).
- Uterine and/or concomitant adnexal pathologies (including malignancy) for which hysteroscopic surgery was not considered either safe or the method to resolve the problem.
- Cardiovascular, hepatic, or renal impairment.
- Allergy to letrozole.
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 |
|---|---|---|
| LetrozoleAlso: FemaraWomen will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention | Drug | Letrozole group |
| PlaceboWomen will be treated with placebo for 10 days before hysteroscopic intervention | Drug | Placebo group |
Primary outcome
Operative time
Time frame: Until 2 hours from the start of operation
Time from start to end of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Yomna Ayman principal investigator
Mansoura University
Mohamed S Abdelhafez, MD study director
Mansoura University
Rafik I Barakat, MD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole in people with Myoma;Uterus, run by Mansoura 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 5 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 28 Apr 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Mohamed S Abdelhafez, MD (+201144523366, msabdelhafez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Until 2 hours from the start of operation). 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 28 Apr 2020.