Clinical Trial: TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy

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

Official Title: A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of TX-12-004-HR in Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy (VVA)

Brief Summary: The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and variability of vulvovaginal atrophy endpoints. In addition, the systemic exposure to estradiol from single and multiple doses of TX-12-004-HR was to be investigated.

Detailed Summary:

This study was a randomized, double-blind, placebo-controlled trial to evaluate safety and efficacy of the TX-12-004-HR formulation in reducing moderate to severe symptoms of vaginal atrophy associated with menopause and to investigate the systemic exposure to estradiol following once daily intravaginal administrations of TX-12-004-HR for 14 days.

Postmenopausal subjects who met the study entry criteria were randomized to one of two treatment groups (TX-12-004-HR or Placebo). During the Screening period subjects were asked to self-assess the symptoms of vulvar and/or vaginal atrophy, including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity and vaginal bleeding associated with sexual activity. Subjects with at least one self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy identified by the subject as being most bothersome to her were eligible to participate in the study.

Current Primary Outcome:

• Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells) [ Time Frame: Baseline to 15 days post-treatment ]
• Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Superficial Cells) [ Time Frame: Baseline to 15 days post-treatment ]
• Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Intermediate Cells) [ Time Frame: Baseline to 15 days post-treatment ]
• Analysis of Change From Baseline to Day 15 in Vaginal pH [ Time Frame: Baseline to 15 days post-treatment ]
• Analysis of Change From Baseline to Day 15 in Severity of the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom [ Time Frame: Baseline to 15 days post-treatment ]
  The severity of the most bothersome VVA symptom was self-assessed by each subject using a VVA questionnaire. The questionnaire has a 4-point scoring scale with: None=0, Mild=1, Moderate=2, and Severe=3. The lower the score, the least bothersome it is to the subject.
• Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity [ Time Frame: Baseline to 15 days post-treatment ]
  Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.
• Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Color) [ Time Frame: Baseline to 15 day
  
  

  Original Primary Outcome:

  • Analysis of Change in Maturation Index of the Vaginal Cell Type [ Time Frame: 2 weeks ]
  • Analysis of Change in Vaginal pH [ Time Frame: 2 weeks ]
  • Analysis of Change in VVA Most Bothersome Symptom [ Time Frame: 2 weeks ]
  • Analysis of Change in Vaginal Bleeding Associated with Sexual Activity [ Time Frame: 2 weeks ]
  • Analysis of Change in Investigator Assessment of the Vaginal Mucosa [ Time Frame: 2 weeks ]
  
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: TherapeuticsMD
  

  Dates:
  Date Received: May 18, 2015
  Date Started: July 2013
  Date Completion:
  Last Updated: November 5, 2015
  Last Verified: November 2015