Status:
COMPLETED
PGL4001 Versus GnRH-agonist in Uterine Myomas
Lead Sponsor:
PregLem SA
Conditions:
Uterine Myomas
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding d...
Eligibility Criteria
Inclusion
- 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.
- Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00740831
Start Date
August 1 2008
End Date
June 1 2010
Last Update
December 17 2012
Active Locations (46)
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1
Medical University Graz
Graz, Austria, 8036
2
Medical University of Innsbruck
Innsbruck, Austria, 6020
3
Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology
Neunkirchen, Austria, 2620
4
Medical University Vienna
Vienna, Austria, 1090