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Aromatase Plus GnRH Analogue Versus Ulippristal Acetate in Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Uterine Fibroid Uterine Bleeding Drug: Ulipristal acetate Drug: Aromatase inhibitor plus GnRH analog Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
Official Title: A Controlled Trial on Uterine Fibroids Treatment Comparing Aromatase Inhibitor Plus GnRH Analogue Versus Ulipristal Acetate
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Bleeding

Arm Intervention/treatment
Active Comparator: Ulipristal acetate
control group treated with Ulipristal acetate as control
Drug: Ulipristal acetate
5.0mg/day of Ulipristal acetate for 3 months
Other Name: Control group

Experimental: Aromatase inhibitor plus GnRH analog
experimental group treated with aromatase inhibitor plus GnRH analog
Drug: Aromatase inhibitor plus GnRH analog
1mg/day of Anastrazole plus 3.6mg/monthly for 3 months
Other Name: experimental group




Primary Outcome Measures :
  1. uterine volume (measured by ultrasound) decrease [ Time Frame: 12 months ]
    uterine volume difference before and after treatment


Secondary Outcome Measures :
  1. uterine bleeding (numbere of episodes) [ Time Frame: 12 months ]
    reduction of number of uterine bleeding after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421639


Contacts
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Contact: MARCO SBRACIA, MD +393479037433 marcandrea@hotmail.com
Contact: FABIO SCARPELLINI, MD +393278779064 ananchekaityche@hotmail.com

Locations
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Italy
Cerm-Hungaria Recruiting
Rome, Italy, 00153
Contact: FABIO SCARPELLINI, MD    +39-3278779064    ananchekaityche@hotmail.com   
Contact: MARCO SBRACIA, MD    +39-3479037433    marcandrea@hotmail.com   
Principal Investigator: FABIO SCARPELLINI, MD         
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Investigators
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Study Chair: MARCO SBRACIA, MD CERM-HUNGARIA

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Responsible Party: Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier: NCT03421639    
Other Study ID Numbers: CR-01-18
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female
Ulipristal acetate
Aromatase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents