Endometrial Polyps Regression With Progesterone Therapy

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Endometrial Polyp

Intervention / Treatment
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* Drug: subcutaneous progesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: watch-and-wait patients<br>patients who receive a watch-and-wait approach | |
| Experimental: Progesterone patients<br>Treatment consists of 7 days of 25 mg subcutaneous progesterone administered from 18° to 25° day of the menstrual cycle and repeated for 3 cycles | Drug: subcutaneous progesterone<br>* 25mg daily for 7 days<br>* Other names: Pleyris;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyps dimensions | Effect of progesterone on polyps dimensions measured in mm | three months after the starting of treatment or of watch-wait approach | 
| 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 | 
| Side effects | Evaluation of any side effects | three months after the starting of treatment | 
| 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 |