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

NCT ID: NCT01965587

Last Updated: 2013-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Menorrhagia

Keywords

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novasure Mirena IUS menorrhagia pelvic pain ashermanns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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novasure mirena IUS combined

novasure mirena IUS combined therapy

Group Type ACTIVE_COMPARATOR

novasure mirena IUS combined

Intervention Type PROCEDURE

novasure mirena IUS combined

novasure alone

Sole treatment with Novasure

Group Type ACTIVE_COMPARATOR

novasure mirena IUS combined

Intervention Type PROCEDURE

novasure mirena IUS combined

Interventions

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novasure mirena IUS combined

novasure mirena IUS combined

Intervention Type PROCEDURE

Other Intervention Names

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Combined treatment Novasure and Mirena IUS

Eligibility Criteria

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Inclusion Criteria

* Anybody suitable for novasure ablation

Exclusion Criteria

* Mirena IUS is indicated as treatment
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Walsall Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Mr jonathan pepper MD FRCOG

Consultant Gynaecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Walsall Manor Hospital

Walsall, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Facility Contacts

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jonathan pepper, frcog

Role: primary

Other Identifiers

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Novasure2013

Identifier Type: -

Identifier Source: org_study_id