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Aromatase Plus GnRH Analogue Versus Ulippristal Acetate in Uterine Fibroids

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ClinicalTrials.gov Identifier: NCT03421639
Recruitment Status : Unknown
Verified January 2018 by Centre for Endocrinology and Reproductive Medicine, Italy.
Recruitment status was:  Recruiting
First Posted : February 5, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy

Tracking Information
First Submitted Date  ICMJE January 30, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date February 7, 2018
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
uterine volume (measured by ultrasound) decrease [ Time Frame: 12 months ]
uterine volume difference before and after treatment
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
uterine dimension decrease [ Time Frame: 12 months ]
uterine volume difference before and after treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
uterine bleeding (numbere of episodes) [ Time Frame: 12 months ]
reduction of number of uterine bleeding after treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2018)
bleeding [ Time Frame: 12 months ]
reduction of uterine bleeding after treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aromatase Plus GnRH Analogue Versus Ulippristal Acetate in Uterine Fibroids
Official Title  ICMJE A Controlled Trial on Uterine Fibroids Treatment Comparing Aromatase Inhibitor Plus GnRH Analogue Versus Ulipristal Acetate
Brief Summary With this study the investigators want to test which is the best medical treatment for symptomatic uterine fibroid, mostly abnormal uterine bleeding, between Ulipristal acetate versus Aromatase inhibitor plus GnRH analog, in term of uterine and fibroid volume reduction
Detailed Description Recently it has been introduced the Ulipristal acetate as medical treatment for symptomatic uterine fibroid. The investigators used in the past for the treatment of other benign gynecological diseases such as endometriosis and adenomyosis a combined therapy with Aromatase inhibitor plus GnRH analog. The investigators also used this combined treatment in selected cases of symptomatic uterine fibroids. With this study the investigators want evaluate which is the best way to treat uterine fibroid, in order to obtain symptoms disappearance other than a fast and long lasting reduction of uterine and fibroid volume. For these reasons the investigators set this controlled trial between Ulipristal acetate (5.0mg/day for 3 months) and GnRH analog plus Aromatase Inhibitor (3.6 mg monthly of Goserelin plus 1.0mg day of Anastrazole for 3 months) and after the treatment patients will be followed up for 12 months
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial in two arms study (75 each one)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Patients will take similar kind medications by an indipendent person
Primary Purpose: Treatment
Condition  ICMJE
  • Uterine Fibroid
  • Uterine Bleeding
Intervention  ICMJE
  • Drug: Ulipristal acetate
    5.0mg/day of Ulipristal acetate for 3 months
    Other Name: Control group
  • Drug: Aromatase inhibitor plus GnRH analog
    1mg/day of Anastrazole plus 3.6mg/monthly for 3 months
    Other Name: experimental group
Study Arms  ICMJE
  • Active Comparator: Ulipristal acetate
    control group treated with Ulipristal acetate as control
    Intervention: Drug: Ulipristal acetate
  • Experimental: Aromatase inhibitor plus GnRH analog
    experimental group treated with aromatase inhibitor plus GnRH analog
    Intervention: Drug: Aromatase inhibitor plus GnRH analog
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 30, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2020
Estimated Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women with healty conditions
  • abnormal menstrual bleeding
  • increased uterine dimensions
  • presence of at least two uterine fibroid

Exclusion Criteria:

  • presence of systemic diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03421639
Other Study ID Numbers  ICMJE CR-01-18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre for Endocrinology and Reproductive Medicine, Italy
Study Sponsor  ICMJE Centre for Endocrinology and Reproductive Medicine, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: MARCO SBRACIA, MD CERM-HUNGARIA
PRS Account Centre for Endocrinology and Reproductive Medicine, Italy
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP