RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia

October 17, 2013 updated by: Mr jonathan pepper MD FRCOG, Walsall Healthcare NHS Trust

RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia. A Pilot Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Endometrial ablation is a commonly used treatment option for women with heavy periods. It is recommended as an initial treatment. It aims at destroying the lining of the womb to reduce heavy menstrual loss.

A hormone releasing device in the womb (MIRENA®)is another commonly used treatment for women with heavy menstrual bleeding and has added benefit of reducing cyclical pain.

There is an increase in the number of women presenting to gynaecology clinic with persistence of pain or cyclical pain with absent or light bleeding after second generation endometrial ablation (Novasure). This may be due to the pockets of active lining of the womb that remains after ablation or possible adhesions created by the treatment. Most women require surgical removal of the womb (hysterectomy) because of pain or a further surgical procedure to divide these adhesions in an attempt to relieve pain and drain any collections in the womb.

We aim to determine if the combined use of MIRENA® and NOVASURE® (which is the second generation endometrial ablation technique used in our unit) will help in reducing the number of women presenting with cyclical pain and requiring further intervention or surgery. The aim of the current study is to compare between women receiving only NOVASURE treatment and women receiving combined NOVASURE and MIRENA treatment for heavy menstrual bleeding. The primary and secondary outcomes will be assessed at 6 and 12 months by a patient questionnaire. The primary outcome is improvement in quality of life The secondary outcomes include

  • Lowering of surgical intervention
  • Reduction in pain
  • Reduction in amount of bleeding This will be a pilot study to determine if the theory is correct and then a larger powered study can be undertaken

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Walsall, West Midlands, United Kingdom, ws29ps
        • Walsall Manor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Anybody suitable for novasure ablation

Exclusion Criteria:

  • Mirena IUS is indicated as treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: novasure mirena IUS combined
novasure mirena IUS combined therapy
Procedure: novasure mirena IUS combined
novasure mirena IUS combined
Other Names:
  • Combined treatment Novasure and Mirena IUS
Active Comparator: novasure alone
Sole treatment with Novasure
Procedure: novasure mirena IUS combined
novasure mirena IUS combined
Other Names:
  • Combined treatment Novasure and Mirena IUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 6 months
Patient questionaire to assess periods and pain
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walsall Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 18, 2013

Study Record Updates

Last Update Posted (Estimate)

October 18, 2013

Last Update Submitted That Met QC Criteria

October 17, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Novasure2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Menorrhagia

Clinical Trials on novasure mirena IUS combined

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe