Vulvodynia is a chronic disorder presenting with genital discomfort, burning and pain. The cause is unknown and symptoms often persist for years causing pain with insertion of tampons, sexual intercourse, pelvic examinations and activities such as bike riding. This was a 3 month , multi centre, open label, parallel group, dose ranging study on the effect of Rectogesic® glyceryl trinitrate 0.2% ointment in women on the relief of symptoms associated with vulvodynia (vulvular vestibulitis syndrome).
The aims of this study were to determine the lowest effective dose of Rectogesic ointment that relieved the symptoms associated with vulvodynia (vulvar vestibulitis syndrome) and to assess the tolerability of Rectogesic ointment use in women.
Study participants were generally healthy women who:
- were 18 to 45 years old
- had vulvodynia for a least 6 months
- experienced pain during intercourse or tampon insertion
Participants in this study trialled an ointment for two months for relieving symptoms of vulvodynia. They attended four visits to the clinic over three months and kept a diary of symptoms during the course of the study.