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

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ClinicalTrials.gov Identifier: NCT01965587
Recruitment Status : Unknown
Verified October 2013 by Mr jonathan pepper MD FRCOG, Walsall Healthcare NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : October 18, 2013
Last Update Posted : October 18, 2013
Sponsor:
Information provided by (Responsible Party):
Mr jonathan pepper MD FRCOG, Walsall Healthcare NHS Trust

Study Description
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Brief Summary:
Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure alone in the treatment of menorrhagia

Condition or disease Intervention/treatment Phase
Menorrhagia Procedure: novasure mirena IUS combined Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia. A Pilot Study
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: novasure mirena IUS combined
novasure mirena IUS combined therapy
 Procedure: novasure mirena IUS combined
novasure mirena IUS combined
Other Name: Combined treatment Novasure and Mirena IUS
Active Comparator: novasure alone
Sole treatment with Novasure
 Procedure: novasure mirena IUS combined
novasure mirena IUS combined
Other Name: Combined treatment Novasure and Mirena IUS


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life [ Time Frame: 6 months ]
    Patient questionaire to assess periods and pain


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Anybody suitable for novasure ablation

Exclusion Criteria:

  • Mirena IUS is indicated as treatment
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965587


Locations
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United Kingdom
Walsall Manor Hospital Not yet recruiting
Walsall, West Midlands, United Kingdom, ws29ps
Contact: jonathan pepper, frcog    00441922721172 ext 7735    jonathan.pepper@walsallhealthcare.nhs.uk   
Principal Investigator: Subashini Sivalingam, MRCOG         
Sponsors and Collaborators
Walsall Healthcare NHS Trust
More Information
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Responsible Party: Mr jonathan pepper MD FRCOG, Consultant Gynaecologist, Walsall Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01965587     History of Changes
Other Study ID Numbers: Novasure2013
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: October 18, 2013
Last Verified: October 2013
Keywords provided by Mr jonathan pepper MD FRCOG, Walsall Healthcare NHS Trust:
novasure
Mirena IUS
menorrhagia
pelvic pain
ashermanns
Additional relevant MeSH terms:
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Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Menstruation Disturbances
 Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral