Endometrial PolypPhase 4NCT06316206
The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation
A Phase 4 study testing Ethinylestradiol/Dienogest 0.03mg/2mg in people with Endometrial Polyp and Endometrial Diseases, run by University of Palermo at 2 sites in Italy.
Trial summary
The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Polyp, Endometrial Diseases
- What is being tested?
- Ethinylestradiol/Dienogest 0.03mg/2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2023to 1 Mar 2024
- 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with endometrial polyps.
Who cannot join
- Patients with other endometrial pathologies.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Use of Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study
The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.
- Conditions
- Endometrial Polyp, Endometrial Diseases
- Being tested
- Ethinylestradiol/Dienogest 0.03mg/2mg
- Keywords
- Hysteroscopy, Endometrial preparation
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinylestradiol/Dienogest 0.03mg/2mgDrug
Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg at any time of the menstrual cycle
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients with endometrial polyps undergone hysteroscopic polipectomy without endometrial preparation. |
| Treatment | Experimental | Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg at any time of the menstrual cycle Receives: Drug: Ethinylestradiol/Dienogest 0.03mg/2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of endometrial preparation
Quality of endometrial preparation assessed visually intraoperatively by the surgeon using a visual analog scale from 0 to 5.
Measured: 14th day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jan 2023
- Primary completion1 Aug 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial PolypStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Andrea Etrusco, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316206
- Sponsor's protocol ID
- EFFIPREP
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Etrusco A, D'Amato A, Agrifoglio V, Chiantera V, Russo G, D'Auge TG, Monti M, Riemma G, Lagana AS, Giannini A. Rapid and random-start endometrial preparation before outpatient hysteroscopic polypectomy in patients of perimenopausal age. Climacteric. 2024 Dec;27(6):561-567. doi: 10.1080/13697137.2024.2404574. Epub 2024 Sep 27.
PubMed 39329272
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT06316206
- Acronym / sponsor ID
- EFFIPREP
- Conditions
- Endometrial Polyp, Endometrial Diseases
- Keywords
- Hysteroscopy, Endometrial preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Mar 2024 (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 presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients with endometrial polyps undergone hysteroscopic polipectomy without endometrial preparation. |
| Treatment | Experimental | Drug: Ethinylestradiol/Dienogest 0.03mg/2mgPatients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg at any time of the menstrual cycle |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with endometrial polyps.
Key exclusion criteria (1 listed)
- Patients with other endometrial pathologies.
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 |
|---|---|---|
| Ethinylestradiol/Dienogest 0.03mg/2mgEndometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg at any time of the menstrual cycle | Drug | Treatment |
Primary outcome
Quality of endometrial preparation
Time frame: 14th day of treatment
Quality of endometrial preparation assessed visually intraoperatively by the surgeon using a visual analog scale from 0 to 5.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 39329272Etrusco A, D'Amato A, Agrifoglio V, Chiantera V, Russo G, D'Auge TG, Monti M, Riemma G, Lagana AS, Giannini A. Rapid and random-start endometrial preparation before outpatient hysteroscopic polypectomy in patients of perimenopausal age. Climacteric. 2024 Dec;27(6):561-567. doi: 10.1080/13697137.2024.2404574. Epub 2024 Sep 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ethinylestradiol/Dienogest 0.03mg/2mg in people with Endometrial Polyp and Endometrial Diseases, run by University of Palermo at 2 sites in Italy.
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 1 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: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of endometrial preparation (time frame: 14th day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06316206, which also lists 1 linked publication.
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 22 Apr 2024.