NCT03309709

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

October 9, 2017

Last Update Submit

January 12, 2019

Conditions

Endometrial Polyp

Outcome Measures

Primary Outcomes (1)

  • Polyps regression rate

    US evidence of normal endometrial line without evidence of polyps

    three months after the starting of treatment or of watch-wait approach

Secondary Outcomes (4)

  • Polyps dimensions

    three months after the starting of treatment or of watch-wait approach

  • Correlation between polyps dimension and regression

    three months after the starting of treatment or of watch-wait approach

  • Side effects

    three months after the starting of treatment

  • Progesterone effects on menstrual bleeding assessed with PBAC (Pictorial blood loss assesment chart) score

    three months after the starting of treatment

Study Arms (2)

watch-and-wait patients

NO INTERVENTION

patients who receive a watch-and-wait approach

Progesterone patients

EXPERIMENTAL

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

Interventions

subcutaneous progesteroneDRUG

25mg daily for 7 days

Also known as: Pleyris
Progesterone patients

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ultrasound diagnosis of endometrial polyps no more than 30 days before the enrollment
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ospedale Pugliese Ciaccio

Catanzaro, Calabria, 88100, Italy

RECRUITING

Federico II University

Naples, 80121, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29729409BACKGROUND

Study Officials

  • Roberta Venturella, MD

    Magna Graecia University of Catanzaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Venturella, MD

CONTACT

+390961883234venturella@unicz.it

Gian Marco Miele, MD

CONTACT

+390961883234gianmarcomiele@live.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 13, 2017

Study Start

October 8, 2017

Primary Completion

October 30, 2019

Study Completion

December 30, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)