Endometrial Polyps Regression With Progesterone Therapy

Last updated: January 12, 2019
Sponsor: University Magna Graecia
Overall Status: Active - Recruiting

Phase

3

Condition

Polyps

Endometrial Cancer

Uterine Fibroids

Treatment

N/A

Clinical Study ID

NCT03309709
Progesterone Polyps
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • signed informed consent

Exclusion

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 Design

Total Participants: 90
Study Start date:
October 08, 2017
Estimated Completion Date:
December 30, 2019

Study 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

Connect with a study center

  • Ospedale Pugliese Ciaccio

    Catanzaro, Calabria 88100
    Italy

    Active - Recruiting

  • Federico II University

    Naples, 80121
    Italy

    Active - Recruiting

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