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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004403-75 | EudraCT Number |
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| Name | Class |
|---|---|
| Gedeon Richter Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulipristal acetate | Active Comparator | ESMYA® : 2 tablets of 5mg per day during 3 months, per os |
|
| Placebo | Placebo Comparator | 2 tablets of 5mg per day during 3 months, per os |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulipristal acetate | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | after 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the PBAC score over 28 days compared to pre-treatment score (J1) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hervé FERNANDEZ, MD, PhD | AP-HP, Bicêtre Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Bicêtre Hospital | Le Kremlin-Bicêtre | 94275 | France |
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| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
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| Drug |
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| 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; | at Day 29 |
| percentage of patients with amenorrhea estimated by a score of PBAC ≤2 on 28 days | 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 | 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), | 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 | 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 | 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 | 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 | Before the treatment and 6 months after beginning of the treatment |
| blood pressure and heart rate, respiratory rate | 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 | Before the treatment and up to 6 months after beginning of the treatment |
| biological examinations: hemoglobin, ferritin, TCA. | Safety assessment | 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. | Before the treatment and up to 6 months after beginning of the treatment |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |