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Endometrial Polyps Regression With Progesterone Therapy

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ClinicalTrials.gov Identifier: NCT03309709
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Roberta Venturella, University Magna Graecia

Tracking Information
First Submitted Date  ICMJE October 9, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE October 8, 2017
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
Polyps regression rate [ Time Frame: three months after the starting of treatment or of watch-wait approach ]
US evidence of normal endometrial line without evidence of polyps
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03309709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Polyps dimensions [ Time Frame: three months after the starting of treatment or of watch-wait approach ]
    Effect of progesterone on polyps dimensions measured in mm
  • Correlation between polyps dimension and regression [ Time Frame: three months after the starting of treatment or of watch-wait approach ]
    Correlation between the size of the polyps and the efficacy of progesterone therapy in terms of regression of lesions
  • Side effects [ Time Frame: three months after the starting of treatment ]
    Evaluation of any side effects
  • Progesterone effects on menstrual bleeding assessed with PBAC (Pictorial blood loss assesment chart) score [ Time Frame: three months after the starting of treatment ]
    Effect of progestogen therapy on symptoms possibly present in patients with endometrial polyps, assessed with PBAC (Pictorial blood loss assesment chart) score. Patients will be asked to fill in the PBAC score during the first menstrual period following diagnosis and during the three months of medical treatment or watch and wait approach. The "8-days PBAC score" is an objective method used to quantify menstrual blood loss; according to this method, each patient records the extent of uterine bleeding during the first 8 days of menstrual cycle, quantizing it in terms of daily change in diapers and number/size of the clots. Each option has a numeric value (1=no bleeding; 2=spotting; 3=1-8 diapers per day; 4=heavy bleeding) and, based on the result obtained, the monthly PBAC score varies from 0 (amenorrhea) to > 500 (heavy bleeding). Menorrhagia occurs when PBAC score is >100 during a menstrual cycle, corresponding to a blood loss greater than 80 ml.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • Polyps dimensions [ Time Frame: three months after the starting of treatment or of watch-wait approach ]
    Effect of progesterone on polyps dimensions measured in mm
  • Correlation between polyps dimension and regression [ Time Frame: three months after the starting of treatment or of watch-wait approach ]
    Correlation between the size of the polyps and the efficacy of progesterone therapy in terms of regression of lesions
  • Side effects [ Time Frame: three months after the starting of treatment ]
    Evaluation of any side effects
  • Progesterone effects on patients symptoms [ Time Frame: three months after the starting of treatment ]
    Effect of progestogen therapy on symptoms possibly present in patients with endometrial polyps, assessed with Visuo Analogic Scale (VAS) scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endometrial Polyps Regression With Progesterone Therapy
Official Title  ICMJE Efficacy of Subcutaneous Progesterone in Premenopausal Woman With Endometrial Polyp: a Multicentric Randomized Control Trial
Brief Summary This prospective randomized study will compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle
Detailed Description

In premenopause, 25% of endometrial polyps regresses spontaneously in 1 year. According to guidelines, given that most premenopausal polyps are not malignant, there is an option for expectant approach with no surgical intervention. Studies on the efficacy of medical treatments for endometrial polyps are also recommended by gynaecologic societies, with the aim of finding cost-saving not invasive strategies to manage this common pathology. Up to now, nobody has investigated the effect of progestin administration on polyps, but molecular and clinical data suggest that the antiestrogenic effect of this hormone can be exploited to increase and speed-up their regression rate. Our preliminary results on the effect of three months of progesterone demonstrated a regression rate of 47,5% in women treated vs 12,5% in those don't receiving treatment.

Accordingly, in this prospective randomized study we aim to compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Polyp
Intervention  ICMJE Drug: subcutaneous progesterone
25mg daily for 7 days
Other Name: Pleyris
Study Arms  ICMJE
  • No Intervention: watch-and-wait patients
    patients who receive a watch-and-wait approach
  • Experimental: Progesterone patients
    Treatment consists of 7 days of 25 mg subcutaneous progesterone administered from 18° to 25° day of the menstrual cycle and repeated for 3 cycles
    Intervention: Drug: subcutaneous progesterone
Publications * Venturella R, Miele G, Cefalì K, Lico D, D'Alessandro P, Arduino B, Di Cello A, Zullo F, Di Carlo C. Subcutaneous Progesterone for Endometrial Polyps in Premenopausal Women: A Preliminary Retrospective Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):143-147. doi: 10.1016/j.jmig.2018.04.023. Epub 2018 May 2.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2019)
90
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2017)
66
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ultrasound diagnosis of endometrial polyps no more than 30 days before the enrollment
  • signed informed consent

Exclusion Criteria:

  • estrogenic and\or progestinic therapy two months before the enrollment
  • tamoxifen therapy
  • pelvic inflammatory disease
  • gynaecologic neoplasia
  • previous chemotherapy and radiotherapy
  • autoimmune diseases, chronic disease, metabolic, and endocrine (hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease)
  • menopause
  • Hypogonadotropic hypogonadism
  • drugs causing menstrual irregularities
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Roberta Venturella, MD +390961883234 venturella@unicz.it
Contact: Gian Marco Miele, MD +390961883234 gianmarcomiele@live.com
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309709
Other Study ID Numbers  ICMJE Progesterone Polyps
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 Roberta Venturella, University Magna Graecia
Study Sponsor  ICMJE University Magna Graecia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberta Venturella, MD Magna Graecia University of Catanzaro
PRS Account University Magna Graecia
Verification Date January 2019

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