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Trial registered on ANZCTR


Registration number
ACTRN12621001101875p
Ethics application status
Submitted, not yet approved
Date submitted
20/06/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain relief following Mirena Intrauterine Device (IUD) insertion: vaginal Diazepam vs placebo
Scientific title
Analgesia following Mirena IUD insertion, a randomised controlled trial: vaginal Diazepam vs placebo.
Secondary ID [1] 304531 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain following Mirena IUD insertion 322402 0
Condition category
Condition code
Reproductive Health and Childbirth 320064 320064 0 0
Contraception
Anaesthesiology 320442 320442 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vaginal Diazepam following Mirena IUD
Once only insertion of 10mg vaginal diazepam pessary by attending clinician immediately following Levonorgestrel Intrauterine Device (LNG-IUD) placement in an outpatient setting.

The vaginal diazepam will be administered once only, by the clinician performing the procedure.

Intervention code [1] 320886 0
Treatment: Drugs
Comparator / control treatment
Placebo
Vaginal pessary - no active drug
1:1 randomisation to active and placebo treatment with stratification based on parity (nulliparous vs multiparous)

Placebo pessary ingredients:
Base, PCCA MBK (TM) (Fatty Acid)
Silica Gel (PPTD) Micronised
Base G (Almond Oil NF (Sweet))
Suppository shell

Control suppositories will be identical in apperance to the active drug suppositories
Control group
Placebo

Outcomes
Primary outcome [1] 327937 0
Assessment of patient self reported pain score (using a numeric pain rating scale) in the first 24 hours following LNG-IUD insertion.
Timepoint [1] 327937 0
Single assessment of patient self reported pain score 24 hours following LNG-IUD insertion
Secondary outcome [1] 397054 0
Assessment of patient self reported pain score (using a numeric pain rating scale) 24-72 hours following LNG-IUD insertion.
Timepoint [1] 397054 0
Single assessment of patient self reported pain score during 24-72 hours following LNG-IUD insertion
Secondary outcome [2] 397055 0
Assessment of patient self reported worst pain score (using a numeric pain rating scale) in the 1st week following LNG-IUD insertion.
Timepoint [2] 397055 0
Data collected at 1 week following insertion
Secondary outcome [3] 397056 0
Discontinuation rate at 3 months’ following insertion
Assessed through proportion of patients who have spontaneously expelled or requested removal of intrauterine devise.
Data collected through RedCap database surveys sent via email to participants
Timepoint [3] 397056 0
3 months’ following insertion
Secondary outcome [4] 397057 0
Adverse effects of treatment assessed in accordance with Common Terminology Criteria for Adverse Events (CTCAE5.0)
Timepoint [4] 397057 0
3 months following insertion

Eligibility
Key inclusion criteria
Premenopausal
Nulliparous or multiparous
Availability of carer to drive patient home from appointment
Access to a computer and email account for completion of questionnaires
Written English language proficiency to provide consent and complete questionnaires
Minimum age
18 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy or contraindication to diazepam or pessary components
Contraindication to outpatient insertion of IUD
Postnatal <6/52
Breastfeeding

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)
Central randomisation by pharmacy producing pessaries
Pessaries packages with numbers corresponding to randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data will be analysed with the assistance of a trained statistician
Pre-defined subgroup analyses of indication for LNG-IUD insertion (pelvic pain or dysfunctional uterine bleeding) and parity are proposed

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19766 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 34408 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 308897 0
Charities/Societies/Foundations
Name [1] 308897 0
Pelvic Pain Foundation of Australia
Address [1] 308897 0
5 Hauteville Terrace, Eastwood, South Australia 5063
Country [1] 308897 0
Australia
Funding source category [2] 308899 0
Hospital
Name [2] 308899 0
Mercy Hospital for Women
Address [2] 308899 0
163 Studley Rd, Heidelberg VIC 3084
Country [2] 308899 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 309823 0
None
Name [1] 309823 0
Address [1] 309823 0
Country [1] 309823 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308798 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 308798 0
163 Studley Road Heidelberg, VIC. 3084
Ethics committee country [1] 308798 0
Australia
Date submitted for ethics approval [1] 308798 0
01/06/2020
Approval date [1] 308798 0
Ethics approval number [1] 308798 0

Summary
Brief summary
Levonorgestral-releasing intrauterine devices (LNG-IUS), such as the Mirena (Bayer), are being increasingly prescribed in Australia. Despite their proven efficacy in contraception, heavy menstrual bleeding and pelvic pain, overall population usage remains low. One of the contributing factors to this is thought to be fear around pain with and following IUD insertion. 59% of nulliparous women reported moderate to severe pain in the first 24 hours following LNG- IUD insertion, reducing to 31% from 24-72 hours.
Vaginal administration of diazepam has been proposed as a treatment for pelvic floor muscle spasm and is recommended for this indication by the Pelvic Pain Foundation of Australia. Diazepam acts as a muscle relaxant and vaginal route of administration prolongs the half-life while allowing local administration. Oral preparations are currently being evaluated (clinicaltrials.gov), however, to our knowledge, no data exists on the impact of vaginal Diazepam administration following IUD insertion.
Our aim is to evaluate the impact of a dose of vaginal diazepam following insertion of the Mirena IUD in an outpatient setting on pelvic pain and cramping. We hypothesise that patients will experience a reduction in post-insertion pain compared to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111922 0
Dr Emma Readman
Address 111922 0
Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084
Country 111922 0
Australia
Phone 111922 0
+61 3 8458 4444
Fax 111922 0
Email 111922 0
ereadman@melbpc.org.au
Contact person for public queries
Name 111923 0
Dr Madeleine Smith
Address 111923 0
Mercy Hospital For Women
163 Studley Road Heidelberg, VIC. 3084
Country 111923 0
Australia
Phone 111923 0
+61 3 8458 4444
Fax 111923 0
Email 111923 0
madeleine.smith@mercy.com.au
Contact person for scientific queries
Name 111924 0
Dr Madeleine Smith
Address 111924 0
Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084
Country 111924 0
Australia
Phone 111924 0
+61 3 8458 4444
Fax 111924 0
Email 111924 0
madeleine.smith@mercy.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected is intended only for use in this study
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 12140 0
Study protocol
Citation [1] 12140 0
Link [1] 12140 0
Email [1] 12140 0
Other [1] 12140 0
Type [2] 12141 0
Informed consent form
Citation [2] 12141 0
Link [2] 12141 0
Email [2] 12141 0
Other [2] 12141 0
Type [3] 12143 0
Ethical approval
Citation [3] 12143 0
Link [3] 12143 0
Email [3] 12143 0
Other [3] 12143 0
Will be available once final revisions complete
Attachment [3] 12143 0
Summary results
No Results