AdenomyosisPhase 2FRA-IIT-UPANCT02587000
Adenomyosis and Ulipristal Acetate
A Phase 2 study testing Ulipristal acetate in people with Adenomyosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Adenomyosis
- 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
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2015to 17 Mar 2020
- Phase
- Phase 2
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Not postmenopausal women aged 30 to 50,
- Accepting to give consent informed in writing,
- Suffering from a symptomatic pelvic endometriosis (menorrhagia isolated or associated with pain)
- Diagnosis information, confirmed the adenomyosis (T2-weighted) MRI and/or transvaginal ultrasonography, in the 6 months preceding the inclusion-having a score of bleeding (PBAC) > 100 from J1 to J8 of the menstruation before the visit of inclusion,
- With an index of body mass (IMC) ≥18 and < 40,
- Using a reliable method of non-hormonal contraception (non-hormonal intrauterine device (IUDs), sexual abstinence, diaphragm, condoms or vasectomy by the partner, or having undergone a surgical sterilization),
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- Willing and able to complete auto-questionnaires in french
- Had no difficulties to understand and communicate with the investigator and his representatives
- Affiliation to a social security or assign.
Who cannot join
- Patient with a hormonal oral contraceptive or with a hormonal intrauterine Device (IUD) contraceptive
- Patient with a history of surgery (other than a caesarean or a cervical conization) uterus, ablation endometrial or uterine artery embolization,
- With other than the endometriosis endometrial pathology,
- Suffering of myoma of type 0, 1, 2 or 3,
- Requiring a transfusion or having a ≤6g/dL hemoglobin
- Existence of systemic coagulation,
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- History of thromboembolism
- Progestagen taking severe disorders in the month preceding the tour selection, and corticosteroids and aspirin in the previous week,
- Existence of Pathology renal, respiratory or cardiac severe or progressive,
- Having a disturbed liver function (defined by the aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT), γGlutamylTranspeptidase, alkaline phosphatase or total bilirubin above 2 times the upper limit of normal),
- Existence or suspicion of malignancy,
- Considering pregnancy in the coming year,
- Pregnant patient or nursing
- Any clinical condition that the investigator considers incompatible with the conduct of the study in terms of acceptable security,
- Participation in courses at another clinical study
- Patient whose accession to the test procedures may be insufficient or for which a long term follow-up seems difficult to achieve
- Person under authorship or curators under safeguard of justice
- History of hypersensitivity to the ulipristal or any of the excipients of ESMYA ® 5 mg tablet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis
Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.
Read the detailed description
After inclusion according to criteria, 2 arms : placebo and Ulipristal acetate (UA) 10mg with randomisation, 1 patient with placebo for 3 patients with UA.
48 patients will be included in this trial. The end point will be the bleeding evaluated by Pictorial Blood-loss Assessment Chart (PBAC) score, the amenorrhea rate and the pain evaluated with visual analogic scale.
- Conditions
- Adenomyosis
- Being tested
- Ulipristal acetate, Placebo
- Keywords
- adenomyosis, ulipristal acetate, sonography, Magnetic resonance imaging [MRI], Pictorial Blood-loss Assessment Chart [PBAC]
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal acetateDrug
Also called ESMYA®
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ulipristal acetate | Active comparator | ESMYA® : 2 tablets of 5mg per day during 3 months, per os Receives: Drug: Ulipristal acetate |
| Placebo | Placebo comparator | 2 tablets of 5mg per day during 3 months, per os Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a control uterine bleeding estimated by a score of Pictorial Blood-loss Assessment Chart (PABC) < 75 of 28 days to the discontinuation of the study (S13)
Measured: after 12 weeks of treatment
Secondary outcomes (14)
Evolution of the PBAC score over 28 days compared to pre-treatment score (J1)
Measured: at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment
Percentage of patients with uterine bleeding control estimated by a score of PBAC < 75 on 28 days
Measured: at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of control of uterine bleeding;
Measured: at Day 29
percentage of patients with amenorrhea estimated by a score of PBAC ≤2 on 28 days
Measured: to week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of amenorrhea
Measured: for the first day of amenorrhea after the treatment
Evolution of pain through a Visual scale analogue between J1 and S5 (J29) S13 (J85) and M6 (S26 S28),
Measured: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution of analgesics using between each visit (number of days of treatment and the percentage of patients without analgesic over each period of 28 days of collection of the PBAC) and by bearing the information provided by the investigator
Measured: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution quality of life questionnaire with Uterine Fibroid Symptom and health related Quality of Life (UFS - QOL) questionnaire
Measured: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution of anemia by hemoglobin and ferritin concentration and coagulation by the CAW
Measured: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evaluation of the adenomyosis by MRI or ultrasound transvaginal : existence/absence, focal length/diffuse, shallow/deep
Measured: Before the treatment and 6 months after beginning of the treatment
blood pressure and heart rate, respiratory rate
Measured: Before the treatment and up to 6 months after beginning of the treatment
Number of participants with adverse events and their grades as assessed by CTCAE v4.0
Measured: Before the treatment and up to 6 months after beginning of the treatment
biological examinations: hemoglobin, ferritin, TCA.
Safety assessment
Measured: Before the treatment and up to 6 months after beginning of the treatment
Frequency of flashes of heat, headache, thickening of the endometrium, uterine bleeding, ovarian cyst.
Measured: Before the treatment and up to 6 months after beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start16 Jun 2015
- Primary completion2 Feb 2018
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Gedeon Richter Ltd.
- Responsible party
- Sponsor
- Investigators
- Hervé FERNANDEZ, MD, PhD, Principal investigator, AP-HP, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587000
- Sponsor's protocol ID
- P141201
- Other IDs
- 2014-004403-75, 2014
- Acronym
- FRA-IIT-UPA
- Status last verified
- Sep 2016
- First submitted
- 29 May 2015
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis
- ClinicalTrials.gov ID
- NCT02587000
- Acronym / sponsor ID
- FRA-IIT-UPA / P141201
- Conditions
- Adenomyosis
- Keywords
- adenomyosis, ulipristal acetate, sonography, Magnetic resonance imaging [MRI], Pictorial Blood-loss Assessment Chart [PBAC]
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Gedeon Richter Ltd.
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 27 Oct 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.
Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.
Detailed description
After inclusion according to criteria, 2 arms : placebo and Ulipristal acetate (UA) 10mg with randomisation, 1 patient with placebo for 3 patients with UA.
48 patients will be included in this trial. The end point will be the bleeding evaluated by Pictorial Blood-loss Assessment Chart (PBAC) score, the amenorrhea rate and the pain evaluated with visual analogic scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulipristal acetate | Active comparator | Drug: Ulipristal acetateESMYA® : 2 tablets of 5mg per day during 3 months, per os |
| Placebo | Placebo comparator | Drug: Placebo2 tablets of 5mg per day during 3 months, per os |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Not postmenopausal women aged 30 to 50,
- Accepting to give consent informed in writing,
- Suffering from a symptomatic pelvic endometriosis (menorrhagia isolated or associated with pain)
- Diagnosis information, confirmed the adenomyosis (T2-weighted) MRI and/or transvaginal ultrasonography, in the 6 months preceding the inclusion-having a score of bleeding (PBAC) > 100 from J1 to J8 of the menstruation before the visit of inclusion,
- With an index of body mass (IMC) ≥18 and < 40,
Key exclusion criteria (18 listed)
- Patient with a hormonal oral contraceptive or with a hormonal intrauterine Device (IUD) contraceptive
- Patient with a history of surgery (other than a caesarean or a cervical conization) uterus, ablation endometrial or uterine artery embolization,
- With other than the endometriosis endometrial pathology,
- Suffering of myoma of type 0, 1, 2 or 3,
- Requiring a transfusion or having a ≤6g/dL hemoglobin
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 acetateAlso: ESMYA® | Drug | Ulipristal acetate |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of patients with a control uterine bleeding estimated by a score of Pictorial Blood-loss Assessment Chart (PABC) < 75 of 28 days to the discontinuation of the study (S13)
Time frame: after 12 weeks of treatment
14 secondary outcomes
Evolution of the PBAC score over 28 days compared to pre-treatment score (J1)
Time frame: at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment
Percentage of patients with uterine bleeding control estimated by a score of PBAC < 75 on 28 days
Time frame: at week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of control of uterine bleeding;
Time frame: at Day 29
percentage of patients with amenorrhea estimated by a score of PBAC ≤2 on 28 days
Time frame: to week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution of the PBAC score calculated from the sum on the 28 days during the treatment period for the first day of amenorrhea
Time frame: for the first day of amenorrhea after the treatment
Evolution of pain through a Visual scale analogue between J1 and S5 (J29) S13 (J85) and M6 (S26 S28),
Time frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution of analgesics using between each visit (number of days of treatment and the percentage of patients without analgesic over each period of 28 days of collection of the PBAC) and by bearing the information provided by the investigator
Time frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution quality of life questionnaire with Uterine Fibroid Symptom and health related Quality of Life (UFS - QOL) questionnaire
Time frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evolution of anemia by hemoglobin and ferritin concentration and coagulation by the CAW
Time frame: between day1 (before treatment) and week5 (day29), week9 (day57), week13 (day85) and month6 (week26, week28) after starting of the treatment (Day1)
Evaluation of the adenomyosis by MRI or ultrasound transvaginal : existence/absence, focal length/diffuse, shallow/deep
Time frame: Before the treatment and 6 months after beginning of the treatment
blood pressure and heart rate, respiratory rate
Time frame: Before the treatment and up to 6 months after beginning of the treatment
Number of participants with adverse events and their grades as assessed by CTCAE v4.0
Time frame: Before the treatment and up to 6 months after beginning of the treatment
biological examinations: hemoglobin, ferritin, TCA.
Time frame: Before the treatment and up to 6 months after beginning of the treatment
Frequency of flashes of heat, headache, thickening of the endometrium, uterine bleeding, ovarian cyst.
Time frame: Before the treatment and up to 6 months after beginning of the treatment
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 27 Sep 2022.
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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.
Hervé FERNANDEZ, MD, PhD principal investigator
AP-HP, Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ulipristal acetate in people with Adenomyosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 inclusion and 18 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 27 Sep 2022. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of patients with a control uterine bleeding estimated by a score of Pictorial Blood-loss Assessment Chart (PABC) < 75 of 28 days to the discontinuation of the study (S13) (time frame: after 12 weeks of treatment). 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 27 Sep 2022.