Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000315415
Ethics application status
Approved
Date submitted
4/04/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A study in healthy women comparing Mi-Gel® and amitriptyline gel applied topically for 6 consecutive days.
Scientific title
A multiple dose, open label, balanced, randomised, two-treatment, two period, two sequence, two-way crossover pilot study comparing Mi-Gel® (containing amitriptyline 5mg/g and estriol 0.3mg/g) to amitriptyline 5mg/g in healthy women under steady state conditions.
Secondary ID [1] 314108 0
None
Universal Trial Number (UTN)
U1111-1312-5229
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvodynia 336906 0
Pudendal neuralgia 336907 0
Vestibulitis 336908 0
Dyspareunia 336909 0
Condition category
Condition code
Anaesthesiology 333369 333369 0 0
Pain management
Renal and Urogenital 333372 333372 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-centre, multiple dose, open label, balanced, randomised, two-treatment, two-period, two-sequence, two-way crossover pilot study with amitriptyline 5mg/g self applied to the vulva twice daily for 5 consecutive days and once on Day 6 separated by a washout period of 14 days in healthy women under steady state conditions.

The intervention for this trial is the test formulation of amitriptyline

This study is a pilot study to determine the pharmacokinetics of amitriptyline in plasma to estimate the number of participants required for a pivotal study.

The study medication will be self-applied in private at the out-patient clinic at approximately 8 am on Study Days 1-5 and at home at approximately 8 pm on Study Days 1-4.

On the evening of Study Days 5 and 26 the participant is confined to our In-patient Clinic for a 1-night stay (about 25 hours on each occasion) for self-application of the study medication and Pharmacokinetic blood samples.

Participants will be monitored for adverse events throughout the study. A diary will completed on a daily basis to record a Vulval Irritation Questionnaire and any adverse events experienced.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed during confinement days. Alcohol breath testing, urine drugs of abuse and pregnancy testing will be performed upon each participant reporting to the Clinical Site 13 hours prior to dosing.

Pre and post study laboratory tests will be completed to assess the health of the participants along with drugs of abuse testing and pregnancy testing.

Adherence to the study protocol will be done by weighing the gel before and after use.
Intervention code [1] 330683 0
Treatment: Drugs
Comparator / control treatment
The comparator/control for this trial is the innovator formulation of Mi-Gel. containing amitriptyline 5mg/g and estriol 0.3mg/g self applied to the vulva twice daily for 5 consecutive days and once on Day 6.
Control group
Active

Outcomes
Primary outcome [1] 340946 0
The pharmacokinetics of amitriptyline in plasma to estimate the number of participants required in the pivotal study comparing Mi-Gel to amitriptyline.
Timepoint [1] 340946 0
A pre-dose sample prior to each morning dose application on study days 1-5 of each period. On study day 6 and 27 the sampling intervals will be at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours after application.
Secondary outcome [1] 445547 0
Additional Pharmacokinetic (PK) of amitriptyline in plasma to estimate the number of participants required in the pivotal study comparing Mi-Gel to amitriptyline.
Timepoint [1] 445547 0
A pre-dose sample prior to each morning dose application on study days 1-5 of each period. On study day 6 and 27 the sampling intervals will be at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours after application.
Secondary outcome [2] 445548 0
To assess the occurrence of adverse events for the single-dose safety and tolerability of the formulations.
Timepoint [2] 445548 0
Continuously from consent until the end of the study
Secondary outcome [3] 445549 0
To investigate any symptoms and side effects of amitriptyline
Timepoint [3] 445549 0
Questionnaires will be administered at screening, baseline (pre-dose) and prior to each dose administration.

Eligibility
Key inclusion criteria
Non-pregnant, assigned at birth females .
Aged between 18 and 65 on day of consent
BMI between 18.5 and 30.0
Non-smoker
Drug free as determined by a Urine Drugs Test
Normal, healthy individuals as determined by medical history, physical examination, ECG, vital signs and laboratory tests
Able to provide written informed consent in English
Able to adhere to all study restrictions and attend all study visits
Consent to GP being contacted if necessary
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known history or presence of any clinically significant medical conditions
Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results as determined by the Investigator.
Women who are pregnant or plan to become pregnant in the next 3 months, or lactating females.
History of genital herpes with >3 outbreaks per year or active non-HPV vaginal infection or vulval infections or irritations, thrush or lichen sclerosis.
Had an abortion or miscarriage within the 3 months prior to randomisation.
A known allergy, hypersensitivity, or intolerance to amitriptyline or Mi-Gel or its excipients.
History of significant alcohol abuse within one year prior to date of consent or regular use of alcohol within six months prior to the date of consent
History of significant drug abuse or dependency within one year prior to date of consent.
Participation in a clinical research study within 30 days prior to Study Day 1
Use of medication other than topical products without significant systemic absorption.
Prescription medication (except prescribed hormonal contraceptive) within 14 days prior to Study Day 1;
Currently taking any of these medications - Alfuzosin, Amiodarone, dronedarone, Ranolazine, Fusidic Acid, Colchicine, Astemizole, terfenadine, Lurasidone, Pimozide, Quetiapine, Dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cisapride, Lovastatin, simvastatin, Avanafil, Sildenafil, Vardenafil, Oral midazolam, triazolam, St. John's wort.
Over-the-counter products and natural health products within 7 days prior to Study Day 1, with the exception of prescribed hormonal contraception which does not contain Estriol.
Donation of platelets or plasma within 30 days prior to Study Day 1.
Participants who are not surgically sterile, post-menopausal or who are sexually active and not using effective contraception for the prevention of pregnancy (i.e. prescribed hormonal contraceptives or other reliable method) for at least 14 days prior to Study Day 1 until 7 days after the Study Exit visit.
Participants of childbearing potential who use a hormonal contraceptive which contains Estriol.
Participants who have poor venous access or cannot tolerate venepuncture, IV cannula insertion or who have a fear of needles or blood
Any participant for whom the Investigator believes, for any reason, inclusion would not be an acceptable risk.
Any clinically significant illness in the 30 days prior to Study Day 1.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be given a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number (randomisation number) after acceptance into the study. Sequence generation will be by using a simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 26932 0
New Zealand
State/province [1] 26932 0
Otago

Funding & Sponsors
Funding source category [1] 318614 0
Commercial sector/Industry
Name [1] 318614 0
Aspen Pharmacare Australia Pty Ltd
Country [1] 318614 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
Country
New Zealand
Secondary sponsor category [1] 321020 0
None
Name [1] 321020 0
Address [1] 321020 0
Country [1] 321020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317218 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 317218 0
Ethics committee country [1] 317218 0
New Zealand
Date submitted for ethics approval [1] 317218 0
16/01/2025
Approval date [1] 317218 0
10/03/2025
Ethics approval number [1] 317218 0
2025 FULL 21519

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

Contacts
Principal investigator
Name 140382 0
Dr Noelyn Hung
Address 140382 0
Zenith Technology Corp Ltd 156 Frederick Street, (PO Box 1777) Dunedin 9016
Country 140382 0
New Zealand
Phone 140382 0
+64 21 48 21 48
Fax 140382 0
Email 140382 0
[email protected]
Contact person for public queries
Name 140383 0
Ms Linda Folland
Address 140383 0
Zenith Technology Corp Ltd 156 Frederick Street, (PO Box 1777) Dunedin 9016
Country 140383 0
New Zealand
Phone 140383 0
+64 3 477 9669
Fax 140383 0
Email 140383 0
[email protected]
Contact person for scientific queries
Name 140384 0
Dr Tak Hung
Address 140384 0
Zenith Technology Corp Ltd 156 Frederick Street, (PO Box 1777) Dunedin 9016
Country 140384 0
New Zealand
Phone 140384 0
+64 3 477 9669
Fax 140384 0
Email 140384 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.