Status:
COMPLETED
Randomized Controlled Trial (RCT)Comparing GYNAECARE MORCELLEX Versus ROTOCUT GI Tissue Morcellators
Lead Sponsor:
University Magna Graecia
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Uterine Myomas
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief Summary
To date, laparoscopic approach may apply to several gynecologic diseases. Among the recent advances in laparoscopy an important role was assumed by the methods of tissue extraction. In particular elec...
Detailed Description
Patients with symptomatic uterine leiomyomas will be assessed for eligibility and will be enrolled in the present protocol-study. At entry, in each woman age, parity, body mass index (BMI), menopausa...
Eligibility Criteria
Inclusion
- Symptomatic uterine leiomyomas with main diameter over 5 cm
Exclusion
- Major medical conditions
- Endocrinologic diseases
- Current or past, acute or chronic psychiatric disorders
- Premenstrual syndrome
- Use of drugs influencing cognition, vigilance and/or mood within six months of the study enrolment
- Hypoechoic or calcified leiomyomas at ultrasound
- Associated lesions in the uterus and adnexa at ultrasound
- Pattern of hyperplasia with cytologic atypia in the endometrial biopsy
- Abnormal Papanicolau smear test
- Positive urine pregnancy test result
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00743080
Start Date
January 1 2008
End Date
January 1 2010
Last Update
November 3 2010
Active Locations (1)
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1
University Magna Graecia
Catanzaro, Italy, Italy, 88100