A study in healthy women comparing Mi-Gel® and amitriptyline gel applied topically for 6 consecutive days.

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.