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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

Tracking Information
First Submitted Date  ICMJE October 15, 2013
First Posted Date  ICMJE October 18, 2013
Last Update Posted Date October 18, 2013
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2013)
Quality of life [ Time Frame: 6 months ]
Patient questionaire to assess periods and pain
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia
Official Title  ICMJE RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia. A Pilot Study
Brief Summary Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure alone in the treatment of menorrhagia
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Menorrhagia
Intervention  ICMJE Procedure: novasure mirena IUS combined
novasure mirena IUS combined
Other Name: Combined treatment Novasure and Mirena IUS
Study Arms  ICMJE
  • Active Comparator: novasure mirena IUS combined
    novasure mirena IUS combined therapy
    Intervention: Procedure: novasure mirena IUS combined
  • Active Comparator: novasure alone
    Sole treatment with Novasure
    Intervention: Procedure: novasure mirena IUS combined
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 17, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Anybody suitable for novasure ablation

Exclusion Criteria:

  • Mirena IUS is indicated as treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01965587
Other Study ID Numbers  ICMJE Novasure2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mr jonathan pepper MD FRCOG, Walsall Healthcare NHS Trust
Study Sponsor  ICMJE Walsall Healthcare NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Walsall Healthcare NHS Trust
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP