Clinical trial NCT03309709: Endometrial Polyps Regression With Progesterone Therapy
Official title: Efficacy of Subcutaneous Progesterone in Premenopausal Woman With Endometrial Polyp: a Multicentric Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endometrial Polyp
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Polyps regression rate
timeFrame: three months after the starting of treatment or of watch-wait approach
Secondary outcomes:
measure: Polyps dimensions
timeFrame: three months after the starting of treatment or of watch-wait approach
measure: Correlation between polyps dimension and regression
timeFrame: three months after the starting of treatment or of watch-wait approach
measure: Side effects
timeFrame: three months after the starting of treatment
measure: Progesterone effects on menstrual bleeding assessed with PBAC (Pictorial blood loss assesment chart) score
timeFrame: three months after the starting of treatment
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Ospedale Pugliese Ciaccio
state: Calabria
city: Naples
country: Italy
facility: Federico II University
Study officials:
affiliation: Magna Graecia University of Catanzaro
name: Roberta Venturella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.