ORIGINAL RESEARCH–WOMEN'S SEXUAL HEALTH
Assessment of Ospemifene or Lubricants on Clinical Signs of VVA
Article first published online: 21 JAN 2014
© 2014 International Society for Sexual Medicine
The Journal of Sexual Medicine
Volume 11, Issue 4, pages 1033–1041, April 2014
How to Cite
Constantine, G., Graham, S., Koltun, W. D. and Kingsberg, S. A. (2014), Assessment of Ospemifene or Lubricants on Clinical Signs of VVA. Journal of Sexual Medicine, 11: 1033–1041. doi: 10.1111/jsm.12428
- Issue published online: 3 APR 2014
- Article first published online: 21 JAN 2014
- Shionogi Inc (Florham Park, NJ).
- Estrogen Agonist/Antagonist;
- Vaginal Examination;
- Vulvar and Vaginal Atrophy
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).
The aim of the study is to assess ospemifene or lubricant use on the clinical signs of VVA.
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.
Main Outcome Measures
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.
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.
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. Constantine G, Graham S, Koltun WD, and Kingsberg SA. Assessment of ospemifene or lubricants on clinical signs of VVA. J Sex Med 2014;11:1033–1041.