An observational study in Uterine Fibroids, sponsored by PregLem SA. Status unknown at 75 sites in 10 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-27.
Sponsored by PregLem SA · Observational
This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA.
The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 150 across 119 observational studies indexed under Leiomyoma.
Browse Leiomyoma studies →PregLem SA is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The target study population will include women who have had a diagnosis of symptomatic uterine fibroids and are initiating preoperative treatment with ESMYA.
Exclusion Criteria:
Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation.
Time frame: Patients will be followed from baseline up to 15 months
This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
PregLem SA