Clinical Trial: Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Pilot Prospective Vulvoscopy With Photography Study of the Visible Changes in the Vulva, Vestibule and Vagina Pre- and Post- Twenty Weeks of Daily Administration of 60 Mg Ospemifene in P

Brief Summary: This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene daily for twenty weeks. After the informed consent is signed, a baseline physical examination, and vulvoscopy with detailed photography of the vulva, vestibule and vagina, will be performed. Physical examination and vulvoscopy with detailed photography of the vulva, vestibule and vagina, will be repeated prospectively every 4 weeks for a total of 20 weeks. Therefore, physical examination and vulvoscopy with detailed photography of the vulva, vestibule and vagina will be performed prospectively at baseline (vulvoscopy session 1), 4 weeks (vulvoscopy session 2), 8 weeks (vulvoscopy session 3), 12, weeks (vulvoscopy session 4), 16 weeks (vulvoscopy session 5) and 20 weeks (vulvoscopy session 6) following daily administration of 60 mg ospemifene.

Detailed Summary:

Ospemifene is indicated for post-menopausal women diagnosed with vulvar vaginal atrophy (VVA) and dyspareunia. While ospemifene clinically significantly reduces pain associated with dyspareunia, there has been little prospective documentation using vulvoscopy with detailed photography of the visible changes to the vulva, vestibule and vaginal region with daily administration of 60 mg ospemifene in post-menopausal women with VVA and dyspareunia. This study will include a total of 6 prospective photographic sessions of the vulva, vestibule and vagina over the 20 weeks administration of 60 mg ospemifene in the study. Comparisons will be made of baseline photography (vulvoscopy session 0) with photography at 4 weeks (vulvoscopy session 1), 8 weeks (vulvoscopy session 2), 12 weeks (vulvoscopy session 3), 16 weeks (vulvoscopy session 4) and 20 weeks (vulvoscopy session 5).

Currently there have been limited prospective studies using vulvoscopy with detailed photography demonstrating visible changes to the vulva, vestibule and vagina following oral administration of 60 mg ospemifene in post-menopausal women with VVA and dyspareunia. Information regarding visible changes to the vulva, vestibule and vagina may be very important to the patient and to the health care provider to best understand the beneficial effects of ospemifene and to ensure patient compliance with treatment.


Sponsor: Sue Goldstein

Current Primary Outcome: Visible changes to the vulva, vestibule and vaginal region on photography [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks,16 weeks and 20 weeks ]

Prospectively document, using vulvoscopy with detailed photography, the visible changes to the vulva, vestibule and vaginal region in post-menopausal women with dyspareunia taking 60 mg daily ospemifene for twenty weeks at 6 timepoints: baseline, 4 weeks, 8 weeks, 12 weeks,16 weeks and 20 weeks.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in pain scale [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks,16 weeks and 20 weeks ]
    Changes in pain as noted on the pain scale (0-3) by q-tip testing of the vestibule by the clinician.
  • Changes in visual scale [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks,16 weeks and 20 weeks ]
    Changes in the vestibule on visual scale (0-3) by the clinician.
  • Changes in pain assessed by subject diary [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks,16 weeks and 20 weeks ]
    Changes in pain as noted on diary by subject.


Original Secondary Outcome: Same as current

Information By: San Diego Sexual Medicine

Dates:
Date Received: May 20, 2016
Date Started: July 2015
Date Completion:
Last Updated: April 17, 2017
Last Verified: September 2016