title: Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR.
abstract: OBJECTIVE
  TX-004HR is an investigational, muco-adhesive, vaginal, softgel capsule containing low-dose, solubilized, 17β-estradiol designed to treat postmenopausal vulvar and vaginal atrophy (VVA) and improve user experience without an applicator and less mess.
  
  
  METHODS
  As part of the 12-week, placebo-controlled, double-blind, phase 3 REJOICE trial evaluating the efficacy/safety of 4-, 10-, and 25-μg TX-004HR in 764 postmenopausal women with VVA, a five-question product survey was administered. Pearson correlation coefficients were used to evaluate correlations between clinical endpoints (vaginal physiology, dyspareunia, and vaginal dryness) and patient acceptability and satisfaction.
  
  
  RESULTS
  Majority of the women receiving TX-004HR or placebo reported that the product was easy to use (85.4%-92.1%) and rated ease of capsule insertion as "good" to "excellent" (75.0%-82.6%). A significantly greater percentage of women reported being "very satisfied" or "satisfied" with TX-004HR (68.6%-76.3%) than with placebo (56.8%, P < 0.05 for all). A greater percentage of women "somewhat" or "very much" preferred TX-004HR over their previous treatment versus those taking placebo (P < 0.05). Significantly more women receiving TX-004HR (72.8%-80.5%) versus placebo (62.5%, P < 0.05) would "probably" or "definitely" consider using the product again. Dyspareunia and vaginal dryness reductions were correlated with higher product satisfaction and the percentage of women who would consider re-using TX-004HR.
  
  
  CONCLUSIONS
  TX-004HR had a high level of product acceptability, and more women were satisfied with TX-004HR, preferred it over their previous treatment, and would consider using it again versus placebo. Women may find TX-004HR to be a more acceptable product than current options to treat their dyspareunia associated with postmenopausal VVA.
authors.affiliation: 1University Hospitals Cleveland Medical Center, Cleveland, OH 2Seattle Women's Health, Research, and Gynecology, Seattle, WA 3San Diego Sexual Medicine, San Diego, CA 4BioMedical Computer Research Institute, Philadelphia, PA 5TherapeuticsMD, Boca Raton, FL 6EndoRheum Consultants, Malvern, PA.
authors.forename: Sheryl A
authors.initials: SA
authors.lastname: Kingsberg
authors.forename: Robin
authors.initials: R
authors.lastname: Kroll
authors.forename: Irwin
authors.initials: I
authors.lastname: Goldstein
authors.forename: Harvey
authors.initials: H
authors.lastname: Kushner
authors.forename: Brian
authors.initials: B
authors.lastname: Bernick
authors.forename: Shelli
authors.initials: S
authors.lastname: Graham
authors.forename: Sebastian
authors.initials: S
authors.lastname: Mirkin
authors.forename: Ginger D
authors.initials: GD
authors.lastname: Constantine
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D001284:Atrophy / Q000188:drug therapy; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States; D014621:Vagina / Q000473:pathology; D014845:Vulvar Diseases / Q000188:drug therapy*
chemical_list: C000626288:TX-004HR; D004958:Estradiol