Endometrial Polyps Regression With Progesterone Therapy

Endometrial Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03309709
• Other study ID #: Progesterone Polyps
• Status: Recruiting
• Phase: Phase 3
• Start date: October 8, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2019
• Source: University Magna Graecia
• Contact: Roberta Venturella, MD
• Phone: +390961883234
• Email: venturella[@]unicz.it
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Polyp
• Polyps
• Uterine Neoplasms

Intervention

Drug:
• subcutaneous progesterone
25mg daily for 7 days

Locations

Country	Name	City	State
Italy	Ospedale Pugliese Ciaccio	Catanzaro	Calabria
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Venturella R, Miele G, Cefalì 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Polyps dimensions	Effect of progesterone on polyps dimensions measured in mm	three months after the starting of treatment or of watch-wait approach
Secondary	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
Secondary	Side effects	Evaluation of any side effects	three months after the starting of treatment
Secondary	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