MenorrhagiaNCT01965587
RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia
A study testing novasure mirena IUS combined in people with Menorrhagia, run by Walsall Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure alone in the treatment of menorrhagia Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menorrhagia
- What is being tested?
- novasure mirena IUS combined
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Anybody suitable for novasure ablation
Who cannot join
- Mirena IUS is indicated as treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Walsall Manor Hospital
Walsall, West Midlands, ws29ps
jonathan pepper, frcog, 00441922721172 ext. 7735, jonathan.pepper@walsallhealthcare.nhs.uk
Subashini Sivalingam, MRCOG
About this study
Official title: 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
Read the 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
- Conditions
- Menorrhagia
- Being tested
- novasure mirena IUS combined
- Keywords
- novasure, Mirena IUS, menorrhagia, pelvic pain, ashermanns
- Medical subject headings
- Menorrhagia, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novasure mirena IUS combinedProcedure or surgery
Also called Combined treatment Novasure and Mirena IUS
novasure mirena IUS combined
| Study group | Role | What they receive |
|---|---|---|
| novasure mirena IUS combined | Active comparator | novasure mirena IUS combined therapy Receives: Procedure: novasure mirena IUS combined |
| novasure alone | Active comparator | Sole treatment with Novasure Receives: Procedure: novasure mirena IUS combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Patient questionaire to assess periods and pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walsall Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr jonathan pepper MD FRCOG, Walsall Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965587
- Sponsor's protocol ID
- Novasure2013
- Status last verified
- Oct 2013
- First submitted
- 15 Oct 2013
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia. A Pilot Study
- ClinicalTrials.gov ID
- NCT01965587
- Acronym / sponsor ID
- Novasure2013
- Conditions
- Menorrhagia
- Keywords
- novasure, Mirena IUS, menorrhagia, pelvic pain, ashermanns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Walsall Healthcare NHS TrustUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| novasure mirena IUS combined | Active comparator | Procedure: novasure mirena IUS combinednovasure mirena IUS combined therapy |
| novasure alone | Active comparator | Procedure: novasure mirena IUS combinedSole treatment with Novasure |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anybody suitable for novasure ablation
Key exclusion criteria (1 listed)
- Mirena IUS is indicated as treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| novasure mirena IUS combinedAlso: Combined treatment Novasure and Mirena IUSnovasure mirena IUS combined | Procedure or surgery | novasure alone, novasure mirena IUS combined |
Primary outcome
Quality of life
Time frame: 6 months
Patient questionaire to assess periods and pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walsall Manor Hospital
Walsall, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novasure mirena IUS combined in people with Menorrhagia, run by Walsall Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2013.