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N/A
18 Years
N/A
Open (Enrolling)
Female
Uterine Fibroids

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Trial Information


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation.

Outcome Time Frame:

Patients will be followed from baseline up to 15 months

Safety Issue:

Yes

Principal Investigator

Jaime Oliver, MD

Investigator Role:

Study Director

Investigator Affiliation:

PregLem SA

Authority:

Germany: Ethics Commission

Study ID:

PGL10-014

NCT ID:

NCT01635452

Start Date:

May 2012

Completion Date:

December 2014

Related Keywords:

  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma

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