Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03309709
Study type Interventional
Source University Magna Graecia
Contact Roberta Venturella, MD
Phone +390961883234
Email venturella@unicz.it
Status Recruiting
Phase Phase 3
Start date October 8, 2017
Completion date December 30, 2019

See also
  Status Clinical Trial Phase
Completed NCT00247923 - Endometrial Polyps: Pathophysiology and Clinical Consequences N/A
Not yet recruiting NCT06295510 - Observational Study of the Association Between Food Intake and Endometrial Polyps
Recruiting NCT03207126 - Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy? N/A
Completed NCT04706000 - Autophagy Markers in Endometrial Polyps
Completed NCT06316206 - The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation Phase 4
Completed NCT06316180 - The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation Phase 4
Completed NCT06316219 - The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Endometrial Preparation Phase 4
Completed NCT06324851 - The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation Phase 4
Completed NCT03790215 - Dydrogesterone in the Treatment of Endometrial Polyps Phase 4
Recruiting NCT01637974 - Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery N/A
Completed NCT05337046 - Hysteroscopic Tissue Removal System Versus Bipolar Resectoscopy for Polypectomy: Long-term Results
Completed NCT05337605 - Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results