Clinical Trial: The Vaginal Health Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The Vaginal Health Trial - Effects of Vaginal Estradiol Tablet and Moisturizing Gel on Postmenopausal Vaginal Symptoms

Brief Summary: This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.

Detailed Summary:

The Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network was established in 2009. By the end of 2014, the network completed 4 clinical trials testing 7 interventions in approximately 1000 women ages 40-62 with vasomotor (VMS) and other menopause symptoms.

The current trial will evaluate a relatively understudied area of menopause - vaginal health and sexual function. This is a 3-arm, randomized, controlled, double-blind, clinical trial among postmenopausal women ages 45-70.

Our primary aim is to evaluate the effectiveness of ultra-low dose vaginal estradiol (Vagifem 10 mcg), non-hormonal hydrophilic non-prescriptive vaginal gel (Replens) and placebo in reducing the Most Bothersome vaginal Symptom (MBS).

Secondary aims include an evaluation of a composite score of vaginal symptoms (dryness, itching, irritation or soreness), sexual function, quality of life and genitourinary atrophy. We will also create a biorepository of vaginal and blood specimens. In a subset of women, we will examine whether treatment response is related to: a) the post-menopausal vaginal microbiome; b) vaginal mucosal inflammation; and c) reproductive hormone profiles. The in-depth focus on the mechanisms associated with postmenopausal vaginal symptoms will use state of the art microbiologic techniques on longitudinally collected biologic specimens and will guide future translational studies.


Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome: Decrease in most bothersome symptoms (MBS) [ Time Frame: Baseline, Week 4, Week 12 ]

Mean change from baseline to 12 weeks in the severity of most bothersome symptom (MBS) on a scale of 0-3, better to worse.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Vaginal Symptoms Index (VSI) [ Time Frame: Weekly and Daily for Weeks 0, 4, 12 ]
    Composite Vaginal Symptoms Index (VSI). [ The VSI is a Modified Bachman scale measuring vaginal dryness, itching, irritation, soreness, and pain with sexual activity among sexually active women, each rated 0=none to 3=severe, and then averaged for a total score of 0-3.
  • Treatment Satisfaction [Likert Scale and Patient Benefit Evaluation] [ Time Frame: Week 12 ]

    Likert Scale 0 = no to 10 = complete satisfaction.

    Patient Benefit Evaluation (PBE) Overall, do you believe that you experienced a meaningful benefit from the study medication? (Yes/No).

  • Sexual Function Index [ Time Frame: Weeks 0, 4, 12 ]

    Female Sexual Function Index (FSFI); Evaluate dyspareunia, sexual function and distress.

    FSFI: A composite score from 2 (not sexually active and no desire) to 36 and 6 domains.

    FSDS-R: a single distress - Item 1, scale 0 - 4, if answer > 0, complete remaining 12 items.

  • MENQOL [ Time Frame: Weeks 0, 4, 12 ]
    Menopausal quality of life (MENQOL) range 1-8, on 29 items (scale of better to worse).
  • Objective measures of genitourinary atrophy [ Time Frame: Weeks 0, 4, 12 ]
    pH (<5 or >5) VMI (% parabasal, intermediate, and superficial cells) Epithelial thickness (Seattle site only)


Original Secondary Outcome:

  • Satisfaction with treatment [ Time Frame: 12 weeks ]
    Satisfaction with treatment (Likert scale and Patient Benefit Evaluation) at follow-up; and mean change from base-line to 12 weeks in
  • Vaginal Symptoms Index (VSI) [ Time Frame: Weeks 0, 4, 12 ]
    Composite Vaginal Symptoms Index (VSI). [The VSI is a Modified Bachman scale measuring vaginal dryness, itching, irritation, soreness, and pain with sexual activity among sexually active women, each rated 0=none to 3=severe, and then averaged for a total score of 0-3]
  • Female Sexual Function Index (FSFI) [ Time Frame: Weeks 0, 4, 12 ]
    Female Sexual Function Index (FSFI) pain domain (scale 0-6, worse to better) among sexually active women and FSFI composite (scale 2-36) among all women, Sexual Function Distress (FSDS) (scale 0-4, better to worse)
  • MENQOL [ Time Frame: Weeks 0, 4, 12 ]
    Menopausal quality of life (MENQOL) (scale 1-8, better to worse); 5) pH (<5; >5); 6) VMI (% parabasal, intermediate, and superficial cells) and epithelial thickness (Seattle site only)


Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: August 3, 2015
Date Started: April 2016
Date Completion: July 2017
Last Updated: January 19, 2017
Last Verified: January 2017