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Spots Global Cancer Trial Database for Endometrial Polyps Regression With Progesterone Therapy

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Trial Identification

Brief Title: Endometrial Polyps Regression With Progesterone Therapy

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

Study ID: NCT03309709

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Ospedale Pugliese Ciaccio, Catanzaro, Calabria, Italy

Federico II University, Naples, , Italy

Contact Details

Name: Roberta Venturella, MD

Affiliation: Magna Graecia University of Catanzaro

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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