Double-blind,randomised,placebo controlled with parallel study design

• Research type

  Research Study

• Full title

  A double-blind, placebo controlled multi-centre study to evaluate the effects of topical Oxytocin on vaginal atrophy in postmenopausal women.

• IRAS ID

  44526

• Contact name

  Joan Pitkin

• Sponsor organisation

  PeP-Tonic Medical AB

• Eudract number

  2009-016613-22

• ISRCTN Number

  N/A

• Research summary

  Oxytocin-gel (Vagitocin) is being developed as a treatment for vaginal atrophy. The purpose of this study is to investigate if and to what extent oxytocin-gel relieves symptoms of and cellular changes associated with vaginal atrophy in postmenopausal women during a 12 week observation period. Oxytocin has been demonstrated to increase wound-healing and a small group of women who has received intravaginal treatment with oxytocin gel has received relief of their symptoms and the appearance of the vaginal mucosa was normalized.?

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/44

• Date of REC Opinion

  30 Jul 2010

• REC opinion

  Further Information Favourable Opinion