ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001101875

Ethics application status

Approved

Date submitted

20/06/2021

Date registered

18/08/2021

Date last updated

7/09/2023

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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Contraception

Anaesthesiology

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]

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]

Assessment of patient self reported pain score (using a numeric pain rating scale) in the first 24 hours following LNG-IUD insertion.

Timepoint [1]

Single assessment of patient self reported pain score 24 hours following LNG-IUD insertion

Secondary outcome [1]

Assessment of patient self reported pain score (using a numeric pain rating scale) 24-72 hours following LNG-IUD insertion.

Timepoint [1]

Single assessment of patient self reported pain score during 24-72 hours following LNG-IUD insertion

Secondary outcome [2]

Assessment of patient self reported worst pain score (using a numeric pain rating scale) in the 1st week following LNG-IUD insertion.

Timepoint [2]

Data collected at 1 week following insertion

Secondary outcome [3]

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]

3 months’ following insertion

Secondary outcome [4]

Adverse effects of treatment assessed in accordance with Common Terminology Criteria for Adverse Events (CTCAE5.0)

Timepoint [4]

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

Sex

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

Suspended

Date of first participant enrolment

Anticipated

1/11/2021

Actual

21/07/2022

Date of last participant enrolment

Anticipated

21/07/2024

Actual

5/01/2023

Date of last data collection

Anticipated

1/11/2024

Actual

10/01/2023

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Mercy Hospital for Women - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Pelvic Pain Foundation of Australia

Address [1]

5 Hauteville Terrace, Eastwood, South Australia 5063

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Mercy Hospital for Women

Address [2]

163 Studley Rd, Heidelberg VIC 3084

Country [2]

Australia

Primary sponsor type

Hospital

Name

Mercy Hospital for Women

Address

163 Studley Rd, Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Health Human Research Ethics Committee

Ethics committee address [1]

163 Studley Road Heidelberg, VIC. 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/06/2020

Approval date [1]

17/12/2021

Ethics approval number [1]

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

Dr Emma Readman

Address

Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084

Country

Australia

Phone

+61 3 8458 4444

Fax

ereadman@melbpc.org.au

Contact person for public queries

Name

Madeleine Smith

Address

Mercy Hospital For Women
163 Studley Road Heidelberg, VIC. 3084

Country

Australia

Phone

+61 3 8458 4444

Fax

madeleine.smith@mercy.com.au

Contact person for scientific queries

Name

Madeleine Smith

Address

Mercy Hospital for Women
163 Studley Road Heidelberg, VIC. 3084

Country

Australia

Phone

+61 3 8458 4444

Fax

madeleine.smith@mercy.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data collected is intended only for use in this study

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
12140	Study protocol		382216-(Uploaded-20-06-2021-19-59-17)-Study-related document.docx
12141	Informed consent form		382216-(Uploaded-20-06-2021-19-59-17)-Study-related document.pdf
12143	Ethical approval	Will be available once final revisions complete

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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