Endometrial Polyps Regression With Progesterone Therapy

NCT ID: NCT03309709

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-08
• Study Completion Date: 2019-12-30

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

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

Conditions

Endometrial Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

watch-and-wait patients

patients who receive a watch-and-wait approach

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

subcutaneous progesterone

Intervention Type: DRUG

25mg daily for 7 days

Interventions

subcutaneous progesterone

25mg daily for 7 days

Intervention Type: DRUG

Other Intervention Names

Pleyris

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Roberta Venturella

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberta Venturella, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University of Catanzaro

Locations

Ospedale Pugliese Ciaccio

Catanzaro, Calabria, Italy

Site Status: RECRUITING

Federico II University

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberta Venturella, MD

Role: CONTACT

venturella@unicz.it

+390961883234

Gian Marco Miele, MD

Role: CONTACT

gianmarcomiele@live.com

+390961883234

Facility Contacts

Roberta Venturella, MD

Role: primary

venturella@unicz.it

+390961883234

Gian Marco Miele, MD

Role: backup

gianmarcomiele@live.com

+390961883234

Gabriele Saccone, MD

Role: primary

00393394685179

Antonio Raffone, MD

Role: backup

References

Venturella R, Miele G, Cefali K, Lico D, D'Alessandro P, Arduino B, Di Cello A, Zullo F, Di Carlo C. Subcutaneous Progesterone for Endometrial Polyps in Premenopausal Women: A Preliminary Retrospective Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):143-147. doi: 10.1016/j.jmig.2018.04.023. Epub 2018 May 2.

Reference Type: BACKGROUND

PMID: 29729409 (View on PubMed)

Other Identifiers

Progesterone Polyps

Identifier Type: -

Identifier Source: org_study_id