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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

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

Condition or disease Intervention/treatment Phase
Endometrial Polyp Drug: subcutaneous progesterone Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Subcutaneous Progesterone in Premenopausal Woman With Endometrial Polyp: a Multicentric Randomized Control Trial
Actual Study Start Date : October 8, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: subcutaneous progesterone
25mg daily for 7 days
Other Name: Pleyris




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Side effects [ Time Frame: three months after the starting of treatment ]
    Evaluation of any side effects

  4. 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.




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03309709


Contacts
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Contact: Roberta Venturella, MD +390961883234 venturella@unicz.it
Contact: Gian Marco Miele, MD +390961883234 gianmarcomiele@live.com

Locations
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Italy
Ospedale Pugliese Ciaccio Recruiting
Catanzaro, Calabria, Italy, 88100
Contact: Roberta Venturella, MD    +390961883234    venturella@unicz.it   
Contact: Gian Marco Miele, MD    +390961883234    gianmarcomiele@live.com   
Sub-Investigator: Alberto Vaiarelli, MD         
Federico II University Recruiting
Naples, Italy, 80121
Contact: Gabriele Saccone, MD    00393394685179      
Contact: Antonio Raffone, MD         
Sub-Investigator: Gabriele Saccone, MD         
Sub-Investigator: Antonio Raffone, MD         
Sponsors and Collaborators
University Magna Graecia
Investigators
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Principal Investigator: Roberta Venturella, MD Magna Graecia University of Catanzaro

Publications:
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Responsible Party: Roberta Venturella, Principal investigator, University Magna Graecia
ClinicalTrials.gov Identifier: NCT03309709     History of Changes
Other Study ID Numbers: Progesterone Polyps
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
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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Progesterone
Polyps
Uterine Neoplasms
Pathological Conditions, Anatomical
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs