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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 (PREMYA)

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ClinicalTrials.gov Identifier: NCT01635452
Recruitment Status : Unknown
Verified January 2015 by PregLem SA.
Recruitment status was:  Active, not recruiting
First Posted : July 9, 2012
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
PregLem SA

Brief Summary:

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


Condition or disease
Uterine Fibroids

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : May 2012
Actual Primary Completion Date : April 2014
Estimated Study Completion Date : March 2016

Group/Cohort
Patients treated with Esmya



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target study population will include women who have had a diagnosis of symptomatic uterine fibroids and are initiating preoperative treatment with ESMYA.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635452


  Show 75 Study Locations
Sponsors and Collaborators
PregLem SA
Investigators
Study Director: Jaime Oliver, MD PregLem SA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT01635452     History of Changes
Other Study ID Numbers: PGL10-014
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases