NCT01829451

Brief Summary

The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion formation after endometrial thermal ablation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Status
completed

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

January 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

1.2 years

First QC Date

March 14, 2013

Last Update Submit

April 10, 2013

Conditions

Menorrhagia

Outcome Measures

Primary Outcomes (1)

  • prevention of intrauterine adhesion formation

    The effect of hyaluronic acid gel on the formation of intrauterine adhesions after endometrial thermal ablation is assessed in an outpatient hysteroscopy after 3 months. Classification of intrauterine adhesions has been created for this study specifically.

    3 months

Study Arms (2)

Hyaluronic acid gel

EXPERIMENTAL

Hyaluronic acid gel is placed into the uterus after endometrial ablation

Other: Hyaluronic acid gel

No hyaluronic acid gel

PLACEBO COMPARATOR

An empty Pipelle device is taken into the uterus after endometrial ablation as an placebo procedure

Interventions

Hyaluronic acid gelOTHER

Hyaluronic acid gel is placed into the uterus after endometrial ablation \--------------------------------------------------------------------------------

Hyaluronic acid gel

Eligibility Criteria

Age35 Years - 52 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • menorrhagia

You may not qualify if:

  • abnormal uterine cavity,
  • abnormal endometrial biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2013

First Posted

April 11, 2013

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

August 1, 2012

Last Updated

April 11, 2013

Record last verified: 2013-04