Intramural FibroidsPhase 3NCT02425878
Ulipristal Acetate 10 mg and Asisted Reproduction
A Phase 3 study testing Ulipristal Acetate in people with Intramural Fibroids and Uterine Fibroids, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Intramural Fibroids, Uterine Fibroids
- What is being tested?
- Ulipristal Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteSpain
- Study dates
- 19 Oct 2015to 31 May 2016
- Phase
- Phase 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients> 18 and <50 years Patients who undergo a first / second cycle OVD Patients who present within 1-3 intramural myomas> 2 cm and <5 cm that do not distort the cavity, Type 3 and 4 of the FIGO classification (Figure 1). Miomas inoperable for medical judgment or patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year before you can submit to TRA Patients who have undergone previous myomectomy who prefer to avoid having surgery
Who cannot join
- History of endometrial changes in patients (hyperplasia) Presence of other endometrial pathologies: polyps, scars of previous cesarean complicated adenomyosis foci, suspected adhesions Simultaneous participation in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results
Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks
- Conditions
- Intramural Fibroids, Uterine Fibroids
- Being tested
- Ulipristal Acetate, Placebo
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal AcetateDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Ulipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks Receives: Drug: Ulipristal Acetate |
| Control | Placebo comparator | Placebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in the rate of clinical pregnancy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start19 Oct 2015
- Primary completion31 May 2016
- Study completion31 May 2016
Why it stopped: Lack of availibility of eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intramural 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Galliano, MDPhD, Principal investigator, Instituto Valenciano de Infertilidad, IVI VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425878
- Sponsor's protocol ID
- 1311-BCN-138-DG
- Status last verified
- Oct 2020
- First submitted
- 21 Apr 2015
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results
- ClinicalTrials.gov ID
- NCT02425878
- Acronym / sponsor ID
- 1311-BCN-138-DG
- Conditions
- Intramural Fibroids, Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of availibility of eligible subjects
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 24 Apr 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.
Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Ulipristal AcetateUlipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks |
| Control | Placebo comparator | Drug: PlaceboPlacebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients> 18 and <50 years Patients who undergo a first / second cycle OVD Patients who present within 1-3 intramural myomas> 2 cm and <5 cm that do not distort the cavity, Type 3 and 4 of the FIGO classification (Figure 1). Miomas inoperable for medical judgment or patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year before you can submit to TRA Patients who have undergone previous myomectomy who prefer to avoid having surgery
Key exclusion criteria (1 listed)
- History of endometrial changes in patients (hyperplasia) Presence of other endometrial pathologies: polyps, scars of previous cesarean complicated adenomyosis foci, suspected adhesions Simultaneous participation in another clinical study
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 |
|---|---|---|
| Ulipristal Acetate | Drug | Experimental |
| Placebo | Drug | Control |
Primary outcome
increase in the rate of clinical pregnancy
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Lack of availibility of eligible subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Related trials for Intramural Fibroids
Not yet recruiting
Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel
Myoma;Uterus, Adhesion; Uterus, Internal
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.
Daniela Galliano, MDPhD principal investigator
Instituto Valenciano de Infertilidad, IVI VALENCIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ulipristal Acetate in people with Intramural Fibroids and Uterine Fibroids, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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: stopped early, as of the sponsor's last update on 14 Oct 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 Spain. 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 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?
The study was stopped early (reason given: Lack of availibility of eligible subjects). 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?
increase in the rate of clinical pregnancy (time frame: 12 weeks). 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 14 Oct 2020.