Endometrial Polyps Regression With Progesterone Therapy

University Magna Graecia

Status and phase: Unknown; Phase 3

Conditions: Endometrial Polyp

Treatments: Drug: subcutaneous progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT03309709

Progesterone Polyps

Details and patient eligibility

About

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

Full 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

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

watch-and-wait patients

No Intervention group

Description:

patients who receive a watch-and-wait approach

Progesterone patients

Experimental group

Description:

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

Treatment:

Drug: subcutaneous progesterone