None listed
Conditions
Brief summary
A randomised, double-blinded study to determine if the application of Mi-Gel to the vulvar vestibule results in reduced impact of pain compared to placebo in patients with entry dyspareunia.
Interventions
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 wil
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.
Sponsors
Women's Health & Research Institute of Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female 2. Aged 18 or over 3. Entry dyspareunia duration of at least 3 months
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
Outcome results
None listed