MyomaNCT03972917
Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy
An observational study of Myoma and Uterine Bleeding, Dysfunctional, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Myoma, Uterine Bleeding, Dysfunctional, Uterine Bleeding Heavy
- What is being tested?
- Transvaginal ultrasonographic examination
- How many people
- 89 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2018to 21 Sep 2021
- Phase
- Observational
- 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
Study population: Italian fertile women who are eligible for conservative treatment for uterine fibroids
Who may be able to join
- number of myomas from 1 to 4
- heavy menstrual bleeding
- conservative treatment request
Who cannot join
- concurrent endometrial pathology
- post-menopausal status
- hepatic pathology
- endocrine or metabolic disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Naples
About this study
Official title: Long-term Observation of Symptomatic Women With Uterine Fibroids Who Have Been Treated With Ulipristal Acetate: Findings on Symptomatology, Morphological Structure, Endometrial Patterns
A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.
- Conditions
- Myoma, Uterine Bleeding, Dysfunctional, Uterine Bleeding Heavy, Dysmenorrhea, Endometrium Hyperplasia
- Being tested
- Transvaginal ultrasonographic examination
- Keywords
- ulipristal acetate, myoma, leiomyoma, endometrial patterns, symptomatology
- Medical subject headings
- Myoma, Metrorrhagia, Dysmenorrhea, Endometrial Hyperplasia, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasonographic examinationDiagnostic test
Evaluation of endometrial thickness; myoma size and volume
| Study group | Role | What they receive |
|---|---|---|
| ulipristal acetate based therapy | Fertile women under ulipristal acetate treatment Receives: Diagnostic Test: Transvaginal ultrasonographic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysmenhorrea (VAS score)
Measured: 12 months
Endometrial thickess (mm)
Measured: 12 months
Myoma's diameter (mm)
Measured: 12 months
Secondary outcomes (1)
Live birth rate (LBR)
Live birth rate if women conceived spontaneously or through ARTs after treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Nov 2018
- Primary completion10 Jul 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Pasquale De Franciscis, University of Campania Luigi Vanvitelli
- Investigators
- Gaetano Riemma, MD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972917
- Sponsor's protocol ID
- N.595
- Status last verified
- Jan 2023
- First submitted
- 21 May 2019
- Last updated
- 18 Jan 2023
- Results posted
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Observation of Symptomatic Women With Uterine Fibroids Who Have Been Treated With Ulipristal Acetate: Findings on Symptomatology, Morphological Structure, Endometrial Patterns
- ClinicalTrials.gov ID
- NCT03972917
- Acronym / sponsor ID
- N.595
- Conditions
- Myoma, Uterine Bleeding, Dysfunctional, Uterine Bleeding Heavy, Dysmenorrhea, Endometrium Hyperplasia
- Keywords
- ulipristal acetate, myoma, leiomyoma, endometrial patterns, symptomatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 4 Jun 2019 (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.
A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ulipristal acetate based therapy | – | Diagnostic Test: Transvaginal ultrasonographic examinationFertile women under ulipristal acetate treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Italian fertile women who are eligible for conservative treatment for uterine fibroids
Key inclusion criteria (3 listed)
- number of myomas from 1 to 4
- heavy menstrual bleeding
- conservative treatment request
Key exclusion criteria (4 listed)
- concurrent endometrial pathology
- post-menopausal status
- hepatic pathology
- endocrine or metabolic disorders
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 |
|---|---|---|
| Transvaginal ultrasonographic examinationEvaluation of endometrial thickness; myoma size and volume | Diagnostic test | ulipristal acetate based therapy |
Primary outcome
Dysmenhorrea (VAS score)
Time frame: 12 months
Endometrial thickess (mm)
Time frame: 12 months
Myoma's diameter (mm)
Time frame: 12 months
1 secondary outcome
Live birth rate (LBR)
Time frame: 12 months
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 18 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Myoma
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingPhase 4
Prescription of Letrozole for Uterine Myoma
Leiomyoma, Uterine, Leiomyoma
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Not yet recruiting
Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
Uterine Fibroids (Leiomyoma), Uterine Myoma
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.
Gaetano Riemma, MD principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myoma and Uterine Bleeding, Dysfunctional, run by University of Campania Luigi Vanvitelli at 1 site 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 3 inclusion and 4 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 18 Jan 2023. 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 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.
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?
Dysmenhorrea (VAS score) (time frame: 12 months). The study lists 3 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 18 Jan 2023.