Status:
UNKNOWN
Endometrial Polyps Regression With Progesterone Therapy
Lead Sponsor:
University Magna Graecia
Conditions:
Endometrial Polyp
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- ultrasound diagnosis of endometrial polyps no more than 30 days before the enrollment
- signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03309709
Start Date
October 8 2017
End Date
December 30 2019
Last Update
January 15 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale Pugliese Ciaccio
Catanzaro, Calabria, Italy, 88100
2
Federico II University
Naples, Italy, 80121