NCT04270994

Brief Summary

Endometrial polyps are one of the main causes of infertility in women. In this work we propose an alternative, effective, economical and safe treatment: the use of misoprostol

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Typical duration for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

February 10, 2020

Last Update Submit

February 13, 2020

Conditions

Endometrial Polyps in Infertile Patients

Outcome Measures

Primary Outcomes (1)

  • Expulsion rate of endometrial polyps

    7 days after misoprostol has been applied

Secondary Outcomes (2)

  • Pregnancy rate after expulsion

    14-21 days after positive β-human Chorionic Gonadotropin (β-hCG)

  • The pregnancy rate after expulsion in patients with primary sterility

    14-21 days after positive β-hCG

Study Arms (1)

Misoprostol

EXPERIMENTAL
Drug: Misoprostol

Interventions

MisoprostolDRUG
Misoprostol

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with uterine polyps diagnosed by endovaginal ultrasound and/or hysterosonography, female ≤ 45 years of age

You may not qualify if:

  • Patients older than 45 years, polyps larger than 60 mm, who did not perform surveillance and/or minimum assessment 6 months after medical management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • HENRY A MATEO-SÁNEZ, MD

    Henry Aristoteles Mate-Sánez

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 17, 2020

Study Start

September 1, 2016

Primary Completion

August 1, 2019

Study Completion

November 1, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share