Description:

ODM derived from http://clinicaltrials.gov/show/NCT00740831

Link:

http://clinicaltrials.gov/show/NCT00740831

Keywords:
Versions (1) ▾
  1. 12/6/13
Uploaded on:

December 6, 2013

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00740831 Uterine Myomas

Details

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 50 Years
Be a pre-menopausal woman between 18 and 50 years inclusive.
Have excessive uterine bleeding due to myoma
Have a myomatous uterus with at least one myoma of >= 3 cm diameter in size
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Body mass index >= 18 and <= 40
Exclusion Criteria
Has a history of or current uterine, cervical, ovarian or breast cancer.
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
Has a known severe coagulation disorder.
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
Has a history of or known current osteoporosis.
Has abnormal hepatic function at study entry.
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Has a current (within twelve months) problem with alcohol or drug abuse.
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
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