About PEARL (PGL4001’s Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata) studies
PEARL I, PEARL II, PEARL III and III extension, PEARL IV are Phase III clinical trials conducted mainly in Europe, all of them have been completed to date. These four studies included pre-menopausal adult women with symptomatic uterine fibroids characterised by heavy menstrual bleeding and eligible for surgery7,42,43,44,45,.
October 2008 – August 2010
PHASE III study-
(PEARL I)
a randomized, parallel-group, double-blind, placebo-controlled, phase 3 trial involved 241 patients. The primary objectives of PEARL I were to demonstrate superior efficacy of ulipristal acetate versus placebo, to reduce excessive uterine bleeding and to reduce total fibroid volume prior to surgery.
October 2008 – August 2010
PHASE III study-
(PEARL II)
a randomized, parallel-group, double-blind, double-dummy, phase 3 trial comparing ulipristal acetate versus the injectable Gonadotropin Releasing Hormone (GnRH) agonist (leuprolide acetate) involved 307 patients.
July 2010 – January 2014
PHASE III –
(PEARL III +PEARL III Extension)
PEARL III and its extension were long-term Phase III, multicentre, double-blind, open-label trials of UPA, open-labelled and placebo-controlled toward the double-blinded administration of progestin (norethisterone acetate [NETA]) after each course to explore any effect on histological endometrial changes and on timing and magnitude of the next menstruation, off-treatment.
June 2012- January 2015
PHASE III –
(PEARL IV)
PEARL IV was a Phase III, multicenter, randomised, double-blind, parallel-group, long-term study investigating the efficacy and safety of UPA 5 mg (ESMYA®) and 10 mg daily for the treatment of uterine fibroids.
