Uterine FibroidsPhase 4NCT02440750
Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women
A Phase 4 study testing operative hysteroscopy, Dienogest and Ulipristal acetate in people with Uterine Fibroids, run by University of Cagliari.
Trial summary
The presence of a thin endometrium has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- operative hysteroscopy, Dienogest and Ulipristal acetate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)
Who cannot join
- pregnancy
- other hormonal therapy in the previous 8 weeks
- hepatic or renal impairment
- any medical condition that would increase the surgical risk
- refusal or unable to sign written consent
About this study
The presence of a thin endometrium has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy.
- Conditions
- Uterine Fibroids
- Being tested
- operative hysteroscopy, Dienogest, Ulipristal acetate
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operative hysteroscopyProcedure or surgery
Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.
DienogestDrug
Also called Visanne
21 days administration of dienogest 2 mg/die
Ulipristal acetateDrug
Also called Esmya
21 days administration of ulipristal acetate 5 mg/die
| Study group | Role | What they receive |
|---|---|---|
| Dienogest | Experimental | Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die Receives: Procedure: operative hysteroscopy; Drug: Dienogest |
| Ulipristal acetate | Experimental | Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die Receives: Procedure: operative hysteroscopy; Drug: Ulipristal acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness
We perform a transvaginal ultrasound (baseline) and we measure the maximum thickness of endometrial line; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm
Measured: Change in mm from baseline after farmacological therapy
Secondary outcomes (3)
Ovarian follicle dimensions
We perform a transvaginal ultrasound (baseline) and we measure the maximum diameter of follicles; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm
Measured: Change in mm from baseline after farmacological therapy
Endometrial appearance
We perform a diagnostic hysteroscopy (baseline) and we describe the endometrial appearance; at the time of surgery (operative hysteroscopy) we describe the endometrial appearance after pharmacological treatment
Measured: Change from baseline after farmacological therapy
Operative time
It will be expressed in minutes
Measured: Within 2 hours after the end of the hysteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJun 2016
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440750
- Sponsor's protocol ID
- HYSTERO
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2015
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women
- ClinicalTrials.gov ID
- NCT02440750
- Acronym / sponsor ID
- HYSTERO
- Conditions
- Uterine Fibroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 12 May 2015 (estimated)
- 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 has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dienogest | Experimental | Procedure: operative hysteroscopy, Drug: DienogestWomen selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die |
| Ulipristal acetate | Experimental | Procedure: operative hysteroscopy, Drug: Ulipristal acetateWomen selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)
Key exclusion criteria (5 listed)
- pregnancy
- other hormonal therapy in the previous 8 weeks
- hepatic or renal impairment
- any medical condition that would increase the surgical risk
- refusal or unable to sign written consent
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 |
|---|---|---|
| operative hysteroscopyPerformed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg. | Procedure or surgery | Dienogest, Ulipristal acetate |
| DienogestAlso: Visanne21 days administration of dienogest 2 mg/die | Drug | Dienogest |
| Ulipristal acetateAlso: Esmya21 days administration of ulipristal acetate 5 mg/die | Drug | Ulipristal acetate |
Primary outcome
Endometrial thickness
Time frame: Change in mm from baseline after farmacological therapy
We perform a transvaginal ultrasound (baseline) and we measure the maximum thickness of endometrial line; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm
3 secondary outcomes
Ovarian follicle dimensions
Time frame: Change in mm from baseline after farmacological therapy
Endometrial appearance
Time frame: Change from baseline after farmacological therapy
Operative time
Time frame: Within 2 hours after the end of the hysteroscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing operative hysteroscopy, Dienogest and Ulipristal acetate in people with Uterine Fibroids, run by University of Cagliari.
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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Endometrial thickness (time frame: Change in mm from baseline after farmacological therapy). 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 9 Mar 2016.