Investigation to assess whether Mi-Gel applied to the vulvar vestibule results in a reduction in pain with intercourse compared to a placebo

Phase 3

Recruiting

• Conditions: entry dyspareunia; Renal and Urogenital - Other renal and urogenital disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12619001163190
• Lead Sponsor: Women's Health & Research Institute of Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pain of vaginal penetration compared to the placebo assessed using a numerical rating scale[baseline and post-treatment scores at 4, 6, 8 weeks (primary timepoint) (end of study [EOS])]