A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids (PREMYA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by PregLem SA
Sponsor:
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT01635452
First received: June 26, 2012
Last updated: April 29, 2013
Last verified: April 2013

June 26, 2012
April 29, 2013
May 2012
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01635452 on ClinicalTrials.gov Archive Site
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A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids
Not Provided

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

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

The target study population will include women who have had a diagnosis of symptomatic uterine fibroids and are initiating preoperative treatment with ESMYA.

Uterine Fibroids
Not Provided
Patients treated with Esmya
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA.

Exclusion Criteria:

  • Patient is pregnant or plans to become pregnant in the next 3 months,
  • Patient is breastfeeding,
  • Patient has genital bleeding of unknown etiology or not due to uterine fibroids,
  • Patient has been diagnosed with uterine, cervical, ovarian or breast cancer,
  • Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrollment,
  • Patient has hypersensitivity to the active substance of ESMYA or to one of its excipients
Female
18 Years and older
No
Contact: Simeon Ocran simeon.ocran@preglem.com
Italy,   United Kingdom,   Poland,   Germany,   France,   Portugal,   Spain,   Austria,   Romania,   Hungary
 
NCT01635452
PGL10-014
No
PregLem SA
PregLem SA
Not Provided
Study Director: Jaime Oliver, MD PregLem SA
PregLem SA
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP