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Trial registered on ANZCTR
Registration number
ACTRN12625000393459
Ethics application status
Approved
Date submitted
24/04/2025
Date registered
1/05/2025
Date last updated
1/05/2025
Date data sharing statement initially provided
1/05/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
A study in healthy women comparing Mi-Gel® and estriol gel applied topically for 6 consecutive days.
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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 estriol 0.3mg/g in healthy women under steady state conditions.
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Secondary ID [1]
314269
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None
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Universal Trial Number (UTN)
U1111-1316-9539
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vulvodynia
337207
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Pudendal neuralgia
337309
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Vestibulitis
337310
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Dyspareunia
337311
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Condition category
Condition code
Anaesthesiology
333617
333617
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0
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Pain management
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Renal and Urogenital
333618
333618
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0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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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 estriol 0.3 mg 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 estriol.
This study is a pilot study to determine the pharmacokinetics of estriol 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.
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Intervention code [1]
330883
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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The pharmacokinetics of estriol in plasma to estimate the number of participants required in the pivotal study comparing Mi-Gel to estriol.
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Assessment method [1]
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Cmax(ss), AUC0-t(ss), Ctau(ss) and DF
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Timepoint [1]
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Three pre-dose samples prior to the first morning application on study day 1 of each period. These will be collected at -1, -0.5 and 0 hours before the dose application. A pre-dose sample prior to each morning dose application on study days 2-5 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.
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Secondary outcome [1]
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Additional Pharmacokinetic (PK) of estriol in plasma to estimate the number of participants required in the pivotal study comparing Mi-Gel to estriol.
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Assessment method [1]
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Tmax(ss) and Cav
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Timepoint [1]
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Three pre-dose samples prior to the first morning application on study day 1 of each period. These will be collected at -1, -0.5 and 0 hours before the dose application. A pre-dose sample prior to each morning dose application on study days 2-5 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.
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Secondary outcome [2]
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To assess the occurrence of adverse events for the single-dose safety and tolerability of the formulation
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Assessment method [2]
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Paper based Diary to record any adverse events which might include local irritation at the site of application, vaginal thrush, drowsiness, dry mouth, breast tenderness, constipation, fluid retention, nausea, post-menopausal spotting, cervical discharge and flu-like symptoms.
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Timepoint [2]
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Continuously from consent until the end of the study
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Secondary outcome [3]
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To investigate any symptoms and side effects of estriol
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Assessment method [3]
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Vulval Irritation Questionnaire which will be assessed as a composite outcome
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Timepoint [3]
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Questionnaires will be administered at screening, baseline (pre-dose) and prior to each dose administration.
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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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 estriol 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, Oralmidazolam, 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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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)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
19/05/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
8
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
27003
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New Zealand
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State/province [1]
27003
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Otago
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Aspen Pharmacare Australia Pty Ltd
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Address [1]
318790
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Country [1]
318790
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Zenith Technology Corporation Limited
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Address
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Country
New Zealand
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Secondary sponsor category [1]
321231
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None
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Name [1]
321231
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Address [1]
321231
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Country [1]
321231
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317398
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
317398
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https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
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Ethics committee country [1]
317398
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New Zealand
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Date submitted for ethics approval [1]
317398
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16/01/2025
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Approval date [1]
317398
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10/03/2025
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Ethics approval number [1]
317398
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2025 FULL 22075
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Summary
Brief summary
This study is a pilot study and its purpose is to compare the pharmacokinetics of estriol to establish the number of participants required for a full-scale bioequivalence study. Pharmacokinetics is a term used to describe how a drug is handled in the body and how it is absorbed into the blood stream. This study will be conducted in two periods, with one formulation applied twice a day for 6 consecutive days in one study period and one formulation applied twice a day for 6 consecutive days in one study period.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Noelyn Hung
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Address
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Zenith Technology Corp Ltd 156 Frederick Street, (PO Box 1777) Dunedin 9016
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Country
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New Zealand
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Phone
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+64 21 48 21 48
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Linda Folland
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Address
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Zenith Technology Corp Ltd 156 Frederick Street, (PO Box 1777) Dunedin 9016
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Country
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New Zealand
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Phone
140935
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+64 3 477 9669
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Fax
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Email
140935
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[email protected]
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Contact person for scientific queries
Name
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Dr Tak Hung
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Address
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Zenith Technology Corp Ltd 156 Frederick Street, (PO Box 1777) Dunedin 9016
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Country
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New Zealand
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Phone
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+64 3 477 9669
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Fax
140936
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Email
140936
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[email protected]
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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.
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