WHO ICTRP trial
Investigation to assess whether Mi-Gel applied to the vulvar vestibule results…
ACTRN12619001163190 · Australian New Zealand Clinical Trials Registry (ANZCTR) · Recruiting
Key facts
| Trial ID | ACTRN12619001163190 |
|---|---|
| Public title | Investigation to assess whether Mi-Gel applied to the vulvar vestibule results in a reduction in pain with intercourse compared to a placebo |
| Scientific title | Randomised, double-blind, placebo-controlled trial assessing the efficacy of Mi-Gel in the treatment of women with entry dyspareunia |
| Primary sponsor | Women's Health & Research Institute of Australia |
| Registry | Australian New Zealand Clinical Trials Registry (ANZCTR) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | Australia |
| Conditions | entry dyspareunia; entry dyspareunia;Renal and Urogenital - Other renal and urogenital disorders;Neurological - Other neurological disorders |
| 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… |
| Registration date | Aug 20, 2019 |
| Target size | 80 |
| Secondary IDs | WHR-CTP-01 |
| Registry page | anzctr.org.au |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: