A study in healthy women comparing two topical gels (Mi-Gel® and estriol gel) applied to the vulva twice daily over 6 consecutive days in two seperate applicaton periods.
A pivotal bioequivalence study comparing estriol in Mi-Gel® topical gel (containing amitriptyline 5mg/g and estriol 0.3mg/g) to estriol 0.3 mg/g topical gel in healthy women in a multiple dose, open label, balanced, randomised, two-treatment, two period, two sequence, two-way crossover bioequivalence study under steady state conditions.
Zenith Technology Corporation Limited
34 participants
Nov 24, 2025
Interventional
Conditions
Summary
In the study we are looking at how much estriol is in blood following multiple applications of each of the study products (Estriol and Mi-Gel). We only measure the ingredient that is common to both products i.e. estriol. If the levels are very similar from both products, the Sponsor can use the results to submit this study to a Regulatory Authority and register their combination product on the market.
Eligibility
Inclusion Criteria9
- 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
Exclusion Criteria19
- 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.
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Interventions
Single-centre, multiple dose, open label, balanced, randomised, two-treatment, two-period, two-sequence, two-way crossover pivotal study with estriol 0.3 mg/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 estriol The randomisation schedule will allocate 50% of participants to the intervention and 50% of participants to the comparator to each study period according to the following sequences. Sequence 1 - Comparator (Period 1) , Innovator (Period 2) Sequence 2 - Innovator (Period 1) , Comparator (Period 2) The study medication will be self-applied in private at the In-patient facility at approximately 8 am on Study Day 1 at the Out-patient facility on Study Days 2-5 and at home at approximately 8 pm on Study Days 1-4 of both study periods. On the evening of Study Day 5 of each study period the participant is confined to our In-patient facility for a 1-night stay (about 25 hours on each occasion) for self-application of the study medication and Pharmacokinetic blood and urine samples. Participants will be monitored for adverse events throughout the study. A diary will completed on a daily basis to record application procedures, a Vulval Irritation Questionnaire and any adverse events experienced. Standard meals will be consumed at our In-Patient facility with no additional food intake allowed during confinement days. Pregnancy testing will be performed on Day 1 prior to dosing & alcohol breath testing, urine drugs of abuse will be performed upon each participant reporting to the In-patient facility on Day 5, 13 hours prior to dosing of each study period.. 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 each tube of gel before and after use.
Locations(1)
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ACTRN12625001284459