Assessment of ospemifene or lubricants on clinical signs of VVA.
BACKGROUND
Ospemifene is a new oral estrogen receptor agonist/antagonist with tissue-selective effects approved for the treatment of moderate to severe dyspareunia, a symptom of postmenopausal vulvar and vaginal atrophy (VVA).


OBJECTIVE
The aim of the study is to assess ospemifene or lubricant use on the clinical signs of VVA.


METHODS
Subjects in three double-blind, placebo-controlled clinical trials were randomized to ospemifene or placebo. In two of the trials, women were provided nonhormonal lubricants for use as needed, and a preplanned evaluation of the frequency of lubricant use was performed. Additionally, a post hoc placebo group analysis for impact of lubricant use or nonuse on physiologic effects of the percentage of superficial and parabasal cells (maturation index) and vaginal pH was conducted. A secondary preplanned end point included visual examination of the vagina (clinical signs of vaginal dryness, petechiae, pallor, friability, and redness of the mucosa) comparing change from baseline to end of treatment for the ospemifene 60-mg/day group and vs. placebo.


METHODS
The primary end points in the phase 3 clinical trials included the percentage of superficial cells, parabasal cells, vaginal pH, and most bothersome symptoms compared with placebo.


RESULTS
There was no significant difference in physiologic effects between placebo lubricant users vs. nonusers in either 12-week study. Compared with baseline, substantially more subjects receiving ospemifene 60 mg/day than placebo showed complete resolution of clinical signs of VVA after 12 and 52 weeks of treatment.


CONCLUSIONS
Ospemifene substantially improved clinical signs of VVA. Within the placebo group, there was no difference in physiologic effects in lubricant users vs. nonusers. Based on gynecologic evaluation of the vagina, benefits were apparent at 12 weeks and sustained for 52 weeks in the ospemifene-treated subjects with significant improvement over placebo. In these three clinical trials, in contrast to ospemifene-treated women, placebo subjects who utilized lubricants had no improvement in their underlying vaginal physiology.
EndoRheum ConsultantsMediaPAUSA. Electronic address: endorheum@gmail.com.
Ginger
G
Constantine
Shionogi Inc.Florham ParkNJUSA.
Shelli
S
Graham
Medical Center for Clinical ResearchSan DiegoCAUSA.
William D
WD
Koltun
Departments of Reproductive Biology and PsychiatryCase Western Reserve UniversityClevelandOHUSA.
Sheryl A
SA
Kingsberg
D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001284:Atrophy / Q000188:drug therapy; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy*; D005260:Female; D006801:Humans; D054327:Lubricants / Q000008:administration & dosage*; D008875:Middle Aged; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage*; D013629:Tamoxifen / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D014621:Vagina / Q000473:pathology*; D014844:Vulva / Q000473:pathology*
D054327:Lubricants; D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C119141:Ospemifene
Estrogen Agonist/Antagonist; Lubricant; Menopause; Ospemifene; Vaginal Examination; Vulvar and Vaginal Atrophy