Endometrial Polyps Regression With Progesterone Therapy

Efficacy of Subcutaneous Progesterone in Premenopausal Woman With Endometrial Polyp: a Multicentric Randomized Control Trial

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

Study Overview

• Status: Unknown
• Conditions: Endometrial Polyp
• Intervention / Treatment: Drug: subcutaneous progesterone

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: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Roberta Venturella, MD; Phone Number: +390961883234; Email: venturella@unicz.it
• Study Contact Backup: Name: Gian Marco Miele, MD; Phone Number: +390961883234; Email: gianmarcomiele@live.com

Study Locations

• Italy
  • Naples, Italy, 80121
    • Recruiting
    • Federico II University
    • Contact: Gabriele Saccone, MD; Phone Number: 00393394685179
    • Contact: Antonio Raffone, MD
    • Sub-Investigator: Gabriele Saccone, MD
    • Sub-Investigator: Antonio Raffone, MD
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • Recruiting
      • Ospedale Pugliese Ciaccio
      • Contact: Roberta Venturella, MD; Phone Number: +390961883234; Email: venturella@unicz.it
      • Contact: Gian Marco Miele, MD; Phone Number: +390961883234; Email: gianmarcomiele@live.com
      • Sub-Investigator: Alberto Vaiarelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Pleyris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyps regression rate	US evidence of normal endometrial line without evidence of polyps	three months after the starting of treatment or of watch-wait approach

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyps dimensions	Effect of progesterone on polyps dimensions measured in mm	three months after the starting of treatment or of watch-wait approach
Correlation between polyps dimension and regression	Correlation between the size of the polyps and the efficacy of progesterone therapy in terms of regression of lesions	three months after the starting of treatment or of watch-wait approach
Side effects	Evaluation of any side effects	three months after the starting of treatment
Progesterone effects on menstrual bleeding assessed with PBAC (Pictorial blood loss assesment chart) score	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.	three months after the starting of treatment

Collaborators and Investigators

• Sponsor: University Magna Graecia

Publications and helpful links

General Publications

• Venturella R, Miele G, Cefali 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2017
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Pathological Conditions, Anatomical; Polyps; Uterine Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: Progesterone Polyps

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No