Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning.

ABSTRACT

OBJECTIVE: Conjugated estrogens/bazedoxifene (CE/BZA) has demonstrated benefit in vulvar-vaginal atrophy (VVA, part of genitourinary syndrome of menopause) and the sexual function domain of the Menopause-specific Quality of Life (MENQOL) questionnaire. The study's objective was to determine the relationship of VVA symptoms and clinical parameters with MENQOL sexual functioning in postmenopausal women receiving VVA treatment. STUDY DESIGN: Post hoc analysis data were derived from the 12-week SMART-3 trial, which evaluated CE/BZA's effect on VVA in nonhysterectomized postmenopausal women (aged 40-65 years) experiencing one or more moderate to severe VVA symptoms (dryness, itching/irritation, pain with intercourse) and vaginal pH>5.0 (N=664). MAIN OUTCOME MEASURES: Repeated measures models were used to determine relationships of VVA symptoms and clinical parameters (vaginal pH, parabasal/superficial cells) with sexual functioning; sensitivity analyses were performed to check assumptions of linearity. RESULTS: VVA symptoms showed an approximately linear relationship with sexual functioning. A 1-point improvement in pain on intercourse (which has a large effect size [ES]=0.85) corresponded to medium improvement (ES=0.57) in MENQOL sexual functioning. Equivalent improvements (in terms of ES) in dryness and itching/irritation corresponded to small to medium (ES=0.35) and small (ES=0.27) improvements in sexual functioning, respectively. The same ES improvement in clinical parameters corresponded to small-trivial improvements in sexual functioning. CONCLUSIONS: VVA symptoms have an approximately linear relationship with sexual functioning. Sexual functioning was most improved when pain on intercourse was reduced. Similar magnitudes of improvements in other VVA symptoms were linked with smaller, though potentially beneficial, improvements in sexual functioning. Changes in clinical parameters had only small or trivial associations with sexual functioning. Trial registration number NCT00238732.