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Trial registered on ANZCTR


Registration number
ACTRN12619001163190
Ethics application status
Approved
Date submitted
17/07/2019
Date registered
20/08/2019
Date last updated
25/11/2021
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation to assess whether Mi-Gel applied to the vulvar vestibule results in a reduction in pain with intercourse compared to a placebo
Scientific title
Randomised, double-blind, placebo-controlled trial assessing the efficacy of Mi-Gel in the treatment of women with entry dyspareunia
Secondary ID [1] 298717 0
WHR-CTP-01
Universal Trial Number (UTN)
U1111-1236-8784
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
entry dyspareunia 313628 0
Condition category
Condition code
Renal and Urogenital 312059 312059 0 0
Other renal and urogenital disorders
Neurological 312252 312252 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
the study investigational product is a gel called Mi-Gel. Mi-Gel is a combination of two registered active ingredients, amitriptyline and oestriol. Participants will be asked to apply 0.5ml of product twice a day to the vulvar vestibule. The study is placebo-controlled with the placebo looking and feeling like the investigational product, but does not have any active ingredients. Participants will use Mi-Gel or the placebo for 8 weeks. This study is double-blinded. Adherence to the study gel will be done by weighing the gel before and after use.
Intervention code [1] 314976 0
Treatment: Drugs
Comparator / control treatment
The control treatment is the placebo which will look and feel like the investigational product. The placebo consists of Pluronic F-127, lecithin and isopropyl palmitate.
Control group
Placebo

Outcomes
Primary outcome [1] 320688 0
Change in pain of vaginal penetration compared to the placebo assessed using a numerical rating scale
Timepoint [1] 320688 0
baseline and post-treatment scores at 4, 6, 8 weeks (primary timepoint) (end of study [EOS])
Secondary outcome [1] 372514 0
composite secondary outcomes are a change in the level of bladder, bowel and sexual function scores from the Australian Pelvic Floor Questionnaire
Timepoint [1] 372514 0
baseline and end of study (8 weeks)
Secondary outcome [2] 372515 0
change in psychological distress measured using the Kessler Psychological Distress Scale
Timepoint [2] 372515 0
baseline and end of study (8 weeks)
Secondary outcome [3] 372516 0
Adverse events will be assessed by the investigators following clinical examination, medical record review and participant consultation.
Adverse events will be reported according to: NHMRC Guidance ‘Safety monitoring and reporting in clinical trials involving therapeutic goods (EH59)’ (November 2016)
Potential adverse events that have been highlighted include vaginal thrush, drowsiness, dry mouth, breast tenderness, constipation, fluid retention, nausea, post menopausal spotting, cervical discharge and flu-like symptoms. These risks are mild and uncommon (occurring less than 1% of the time). Headaches may occur which could be moderately uncomfortable but are also uncommon. Other, less common (occurring less than 1% of the time) side effects which are reported when using much higher doses of amitriptyline (one of the active ingredients in Mi-Gel) are classed as mild and include, sedation, tinnitus and blurring of vision.
Timepoint [3] 372516 0
measured at each study visit, visit 2 (10 days) and EOS visit (56 days/8 weeks) or at unscheduled visits between day 1 and day 56.
Secondary outcome [4] 372517 0
Impact of pain on daily life compared to the placebo assessed using the Pelvic Pain Impact Questionnaire.
Timepoint [4] 372517 0
baseline and end of study (8 weeks)

Eligibility
Key inclusion criteria
1. Female
2. Aged 18 or over
3. Entry dyspareunia duration of at least 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Aged less than 18
2. Not sexually active
3. Current use of amitriptyline or oestriol (topical or oral)
(Patients would be suitable for inclusion after a wash out period of six weeks)
4. Pudendal Nerve Block procedure within the last three months or planning on having a Pudendal Nerve Block procedure during the course of the trial
5. Known allergy to amitriptyline or oestriol
6. Contraindication to use of amitriptyline or oestriol
7. Pregnant or unwilling to use methods to avoid potential pregnancy, as determined by a urine test
8. Other peri-vaginal infections or vulvovaginal disorders including current acute/chronic candidiasis or active DIV/psoriasis/lichen sclerosis
9. Endometrial hyperplasia or undiagnosed genital bleeding
10. Previous myocardial infarction, thrombosis, breast cancer, cancer of any sexual organs, liver disease and/or porphyria
11. History of chemotherapy or radiation therapy
12. Lack of lubrication due to chronic conditions such as diabetes mellitus, atherosclerosis or auto-immune disorders
13. Current diagnosis of vaginismus
14. The investigator believes the candidate would not make a good clinical trial patient

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)
Allocation was concealment and was carried out using central randomisation by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomised 1:1 ratio using sequence randomisation in block groups of 10.
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
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Total sample size will be 80 after consideration of dropout rate of 20%.
The sample size calculation was conducted in PS: Power and Sample Size Calculation version 3.1.6, October 2018 (Dupont WD, Plummer WD: 'Power and Sample Size Calculations: A Review and Computer Program', Controlled Clinical Trials 1990; 11:116-28.or)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/09/2019
Actual
11/11/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
2/03/2022
Actual
Sample size
Target
80
Accrual to date
56
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14215 0
Women’s Health and Research Institute of Australia - Sydney
Recruitment postcode(s) [1] 27197 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 303270 0
Commercial sector/Industry
Name [1] 303270 0
Women's Health & Research Institute of Australia
Country [1] 303270 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Women's Health & Research Institute of Australia
Address
Level 12
97-99 Bathurst St
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 303282 0
None
Name [1] 303282 0
Address [1] 303282 0
Country [1] 303282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303808 0
Bellberry
Ethics committee address [1] 303808 0
Ethics committee country [1] 303808 0
Australia
Date submitted for ethics approval [1] 303808 0
10/07/2019
Approval date [1] 303808 0
03/09/2019
Ethics approval number [1] 303808 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94882 0
Dr Karen Chan
Address 94882 0
Women's Health & Research Institute of Australia
Level 12
97-99 Bathurst St
Sydney NSW 2000
Country 94882 0
Australia
Phone 94882 0
+61 2 8197 4400
Fax 94882 0
+61 2 8021 1244
Email 94882 0
karen.chan1@health.nsw.gov.au
Contact person for public queries
Name 94883 0
Elena Elefantis
Address 94883 0
Mobius Medical Suite 1402B 275 Alfred St North Sydney NSW 2060
Country 94883 0
Australia
Phone 94883 0
+61 2 8317 5460
Fax 94883 0
+61 2 8317 5461
Email 94883 0
elena@mobiusmedical.com.au
Contact person for scientific queries
Name 94884 0
Thierry Vanciallie
Address 94884 0
Women's Health & Research Institute of Australia
Level 12
97-99 Bathurst St
Sydney NSW 2000
Country 94884 0
Australia
Phone 94884 0
+61 1300 722 206
Fax 94884 0
+61 2 8021 1244
Email 94884 0
info@whria.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
There are no plans for individual participant data to be made available at the completion of the trial. Data sets may be distributed if a request is made in writing to WHRIA.


What supporting documents are/will be available?

No Supporting Document Provided



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.