A Phase 3 interventional study of subcutaneous progesterone in Endometrial Polyp, sponsored by University Magna Graecia. Status unknown at 2 sites in Italy. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by University Magna Graecia · Phase 3, Interventional, and Treatment
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
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
Exclusion Criteria:
patients who receive a watch-and-wait approach
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
25mg daily for 7 days
Also known as: Pleyris
Polyps regression rate
US evidence of normal endometrial line without evidence of polyps
Time frame: three months after the starting of treatment or of watch-wait approach
Polyps dimensions
Effect of progesterone on polyps dimensions measured in mm
Time frame: 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
Time frame: three months after the starting of treatment or of watch-wait approach
Side effects
Evaluation of any side effects
Time frame: 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.
Time frame: three months after the starting of treatment
Plan to share: No
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University Magna Graecia