NCT01965587

Brief Summary

Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure alone in the treatment of menorrhagia

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

October 18, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

October 15, 2013

Last Update Submit

October 17, 2013

Conditions

Menorrhagia

Keywords

novasureMirena IUSmenorrhagiapelvic painashermanns

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Patient questionaire to assess periods and pain

    6 months

Study Arms (2)

novasure mirena IUS combined

ACTIVE COMPARATOR

novasure mirena IUS combined therapy

Procedure: novasure mirena IUS combined

novasure alone

ACTIVE COMPARATOR

Sole treatment with Novasure

Procedure: novasure mirena IUS combined

Interventions

novasure mirena IUS combinedPROCEDURE

novasure mirena IUS combined

Also known as: Combined treatment Novasure and Mirena IUS
novasure alonenovasure mirena IUS combined

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Anybody suitable for novasure ablation

You may not qualify if:

  • Mirena IUS is indicated as treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walsall Manor Hospital

Walsall, West Midlands, ws29ps, United Kingdom

Location

MeSH Terms

Conditions

MenorrhagiaPelvic Pain

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gynaecologist

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 18, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Last Updated

October 18, 2013

Record last verified: 2013-10

Locations

GB(1)