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This is a phase III, multicentre, long-term open-label extension of the phase III study: Pearl IIIextension (PGL09-027). During Pearl III (PGL09-026) and subsequent Pearl III extension (PGL09-027), patients have been exposed to a total of 4 cycles of daily 3month open-label treatment with ulipristal acetate 10mg before entering the proposed study Pearl extension 2 (PGL11-024).
This proposed study consists of 4 further consecutive courses of 3 months (84 days) open label ulipristal acetate 10mg once daily treatment each separated by a drug free period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulipristal Acetate (PGL4001) 10mg | Experimental | Ulipristal Acetate (PGL4001)10mg daily administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulipristal Acetate - open label | Drug | Ulipristal Acetate (PGL4001) tablets 10mg orally daily for 3 months (84 days) for each treatment course. There are four 3-month treatment courses in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire | Average score of the first 3 questions. | 9 months |
| Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire | Average score of the first 3 questions. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elke Bestel, Dr | PregLem SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Vienna | 1090 | Austria | |||
| Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique, |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| Brussels |
| 1200 |
| Belgium |
| CHR de la Citadelle | Liège | 4000 | Belgium |
| Cliniques Universitaires UCL de Mont-Godinne | Yvoir | 5530 | Belgium |
| Prywatna Klinika Polozniczo-Ginekologiczna | Bialystok | 15-224 | Poland |
| INVICTA Sp. Z o.o. | Gdansk | 80-895 | Poland |
| Private practice | Katowice | 40-724 | Poland |
| Prywatny Gabinet Lekarski Ginekologia I Poloznictwo Ultrasonografia | Lodz | 90-602 | Poland |
| Specjalistyczny Gabinet Ginekologiczno-Polozniczy | Lublin | 20-064 | Poland |
| Gabinet Lekarski Specjalistyczny "Sonus" | Warsaw | 02-066 | Poland |
| Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Poloznictwa, Chorob Kobiecych i Ginekologii Onkologicznej | Warsaw | 02-507 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, I Katedra i Klinika Ginekologii i Położnictwa | Wroclaw | 50-369 | Poland |
| Hospital Universitario Vall Hebrón (Gynecology department) Edificio Maternal | Barcelona | 08035 | Spain |
| Clinica Ginecologica CEOGA | Lugo | 27002 | Spain |
| Private Practice | Madrid | 28009 | Spain |
| HOSPITAL Universitario 12 de Octubre y Fundación de Investigación Biomédica Hospital 12 de Octubre | Madrid | 28041 | Spain |