Endometrial Polyps Regression With Progesterone Therapy
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: watch-and-wait patients patients who receive a watch-and-wait approach |
|
| Experimental: Progesterone patients 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Polyps regression rate [three months after the starting of treatment or of watch-wait approach]
US evidence of normal endometrial line without evidence of polyps
Secondary Outcome Measures
- Polyps dimensions [three months after the starting of treatment or of watch-wait approach]
Effect of progesterone on polyps dimensions measured in mm
- Correlation between polyps dimension and regression [three months after the starting of treatment or of watch-wait approach]
Correlation between the size of the polyps and the efficacy of progesterone therapy in terms of regression of lesions
- Side effects [three months after the starting of treatment]
Evaluation of any side effects
- Progesterone effects on menstrual bleeding assessed with PBAC (Pictorial blood loss assesment chart) score [three months after the starting of treatment]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ospedale Pugliese Ciaccio | Catanzaro | Calabria | Italy | 88100 |
| 2 | Federico II University | Naples | Italy | 80121 |
Sponsors and Collaborators
- University Magna Graecia
Investigators
- Principal Investigator: Roberta Venturella, MD, Magna Graecia University of Catanzaro
Study Documents (Full-Text)
None provided.More Information
Publications
- Progesterone Polyps