ID

4274

Beschrijving

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

Link

http://clinicaltrials.gov/show/NCT00740831

Trefwoorden

  1. 06-12-13 06-12-13 - Martin Dugas
Geüploaded op

6 december 2013

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility NCT00740831 Uterine Myomas

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Alter 18 bis 50 Jahre
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.
BMI >= 18 und <= 40
Ausschlusskriterien
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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