Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial.

Abstract

OBJECTIVE:

To evaluate the response of the vaginal mucosa with TX-004HR and its correlation with vulvar and vaginal atrophy (VVA) symptoms, and whether visual examination is a useful measure for assessing VVA.

METHODS:

REJOICE was a 12-week, phase 3, multicenter, randomized, double-blind, placebo-controlled study of a vaginal, muco-adhesive, 17β-estradiol softgel capsule (TX-004HR 4, 10, and 25 μg) in postmenopausal women with VVA and moderate-to-severe dyspareunia. Treatments were self-administered vaginally once per day for 2 weeks, then twice per week for 10 weeks. The vagina was visually examined at baseline and at weeks 2, 6, 8, and 12; changes were evaluated using a 4-item scale for vaginal color, vaginal epithelial integrity, vaginal epithelial surface thickness, and vaginal secretions.

RESULTS:

Significant improvements were observed with all three TX-004HR doses versus placebo in vaginal color (least square mean score changes of -0.96 to -1.06 for TX-004HR doses vs -0.60 for placebo at week 12), epithelial integrity (-0.97 to -1.07 vs -0.60), epithelial surface thickness (-0.94 to -1.03 vs -0.61), and secretions (-1.01 to -1.06 vs -0.64) (P < 0.001 for all comparisons at all time points). Both Pearson's correlations and logistic regression receiver-operating characteristic curve analyses significantly correlated the sum of the individual visual assessment scores with dyspareunia (P < 0.0001) and vaginal dryness (P < 0.0001) at 12 weeks.

CONCLUSIONS:

Greater improvements in the vaginal mucosa of postmenopausal women with VVA and moderate-to-severe dyspareunia were observed with TX-004HR versus placebo, and vaginal mucosa assessment scores correlated with vaginal symptoms of dyspareunia and dryness. Visual vaginal assessment by healthcare professionals is a useful measure for diagnosing VVA and assessing response to treatment.

• Authors: James A Simon, David F Archer, Risa Kagan, Brian Bernick, Shelli Graham, Ginger D Constantine, Sebastian Mirkin
• Journal: Menopause (New York, N.Y.) (Menopause) Vol. 24 Issue 9 Pg. 1003-1010 (Sep 2017) ISSN: 1530-0374 [Electronic] United States
• PMID: 28419068 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Placebos
• TX-004HR
• Estradiol

Topics

• Administration, Intravaginal
• Aged
• Atrophy (drug therapy)
• Color
• Double-Blind Method
• Dyspareunia (drug therapy)
• Epithelium (pathology)
• Estradiol (administration & dosage)
• Female
• Humans
• Middle Aged
• Mucous Membrane (pathology)
• Placebos
• Postmenopause
• ROC Curve
• Treatment Outcome
• Vagina (metabolism, pathology)
• Vaginal Diseases (drug therapy)
• Vulva (pathology)
• Vulvar Diseases (drug therapy, pathology)