Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000029392
Ethics application status
Approved
Date submitted
15/01/2008
Date registered
18/01/2008
Date last updated
23/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Mirena Intra-Uterine System: Does it Improve Long Term Symptoms in Women with Chronic Pelvic Pain and/or Endometriosis after Laparoscopy?
Scientific title
Mirena Intra-Uterine System: Does it Improve Long Term Symptoms in Women with Chronic Pelvic Pain and/or Endometriosis after Laparoscopy?

A multicentre randomized placebo-controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pelvic Pain in women in reproductive age 2721 0
Condition category
Condition code
Reproductive Health and Childbirth 2841 2841 0 0
Menstruation and menopause
Reproductive Health and Childbirth 252443 252443 0 0
Contraception
Reproductive Health and Childbirth 252451 252451 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mirena is a levonorgestrel-releasing intrauterine system, which consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir. The reservoir consists of a cylinder, made of a mixture of levonorgestrel and silicone containing a total of 52 mg levonorgestrel. Low doses of levonorgestrel can be administered into the uterine cavity with the MIRENA intrauterine delivery system. Initially, levonorgestrel is released at a rate of approximately 20 µg/day. This rate decreases progressively to half that value after 5 years.
Intervention code [1] 2456 0
Treatment: Devices
Intervention code [2] 2467 0
Other interventions
Comparator / control treatment
Placebo Intrauterine System Insertion, is the inactive form of the intrauterine system. It contain empty reservoir, thus no hormone included.
Control group
Placebo

Outcomes
Primary outcome [1] 3724 0
Daily ratings (NRS) of dysmenorrhoea
Timepoint [1] 3724 0
01/02/2008 till 01/02/2010
Primary outcome [2] 3725 0
Daily ratings using numerical rating scale (NRS) of pelvic pain
Timepoint [2] 3725 0
01/02/2008 till 01/02/2010
Secondary outcome [1] 6284 0
Use of rescue analgesia/therapies including an NRS before use and a record of the indication
Timepoint [1] 6284 0
01/02/2008 till 01/02/2010
Secondary outcome [2] 6285 0
Quality of life using Endometriosis Health Profile (EHP)-30 with separate and total scores
Timepoint [2] 6285 0
01/02/2008 till 01/02/2010
Secondary outcome [3] 6286 0
Study specific adverse event questionnaires with direct questions and free text administered at the same time points as the EHP-30
Timepoint [3] 6286 0
01/02/2008 till 01/02/2010

Eligibility
Key inclusion criteria
All women with pelvic pain and or dysmenorrhoea
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute pelvic inflammatory disease (PID) and or positive swab for Chlamydia +/- Gonorrhea
2. Chronic PID as defined by the presence of tubal damage (hydrosalpinx, hydrosalpinges) noted at surgery
3. Breast feeding women
4. Positive pregnancy urinary test or plan for a pregnancy within 12 months after enrollment
5. Previous hysterectomy
6. Contraindications to laparoscopy and/or anesthesia
7. Contraindication to the use of IUS according to WHO criteria
8. Hormonal treatment within the last three months
9. Malignancies
10. Known ovarian cysts other than endometriotic
10. Intention to use other medical treatment that may affect pelvic pain scores within 12 month
11. Use of hormonal treatments in the last three months prior to trial recruitment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study centers will be provided with individually sealed packages containing the treatment for each patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 552 0
2750
Recruitment postcode(s) [2] 553 0
2148
Recruitment postcode(s) [3] 554 0
2145

Funding & Sponsors
Funding source category [1] 2971 0
University
Name [1] 2971 0
University of Sydney
Country [1] 2971 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Early Pregnancy, Gynaecological Ultrasound and Advanced Endoscopic Unit
Nepean Centre for Perinatal Care
Nepean Clinical School.
Nepean Hospital
Penrith 2750, NSW
Country
Australia
Secondary sponsor category [1] 2679 0
Hospital
Name [1] 2679 0
Nepean Hospital
Address [1] 2679 0
Early Pregnancy, Gynaecological Ultrasound and Advanced Endoscopic Unit
Nepean Centre for Perinatal Care
Nepean Clinical School.
Nepean Hospital
Penrith 2750, NSW
Country [1] 2679 0
Australia
Secondary sponsor category [2] 251411 0
None
Name [2] 251411 0
New secondary sponsor name. Please modify.
Address [2] 251411 0
New secondary sponsor address. Please modify.
Country [2] 251411 0
Secondary sponsor category [3] 251420 0
None
Name [3] 251420 0
New secondary sponsor name. Please modify.
Address [3] 251420 0
New secondary sponsor address. Please modify.
Country [3] 251420 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4918 0
Sydney West Area Health Service Human Researche Ethics Committee, Nepean Campus
Ethics committee address [1] 4918 0
Ethics committee country [1] 4918 0
Australia
Date submitted for ethics approval [1] 4918 0
16/01/2008
Approval date [1] 4918 0
Ethics approval number [1] 4918 0
Ethics committee name [2] 4934 0
Ethics committee address [2] 4934 0
Ethics committee country [2] 4934 0
Date submitted for ethics approval [2] 4934 0
16/01/2008
Approval date [2] 4934 0
Ethics approval number [2] 4934 0

Summary
Brief summary
The null hypothesis is: Women with pelvic pain and or dysmenorrhoea who undergo laparoscopy and insertion of Mirena IUS will have a reduction in symptoms of at least 50% at 12 months follow-up (primary point).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28301 0
Address 28301 0
Country 28301 0
Phone 28301 0
Fax 28301 0
Email 28301 0
Contact person for public queries
Name 11458 0
George Condous
Address 11458 0
Early Pregnancy, Gynaecological Ultrasound and Advanced Endoscopic Unit
Nepean Centre for Perinatal Care
Nepean Clinical School.
Nepean Hospital
Penrith 2750, NSW
Country 11458 0
Australia
Phone 11458 0
(02) 4734 2000
Fax 11458 0
Email 11458 0
[email protected]
Contact person for scientific queries
Name 2386 0
George Condous
Address 2386 0
Early Pregnancy, Gynaecological Ultrasound and Advanced Endoscopic Unit
Nepean Centre for Perinatal Care
Nepean Clinical School.
Nepean Hospital
Penrith 2750, NSW
Country 2386 0
Australia
Phone 2386 0
(02) 4734 2000
Fax 2386 0
Email 2386 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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