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Effects of ospemifene on genitourinary health assessed by prospective vulvar-vestibular photography and vaginal/vulvar health indices

Goldstein, Irwin MD1; Simon, James A. MD2; Kaunitz, Andrew M. MD3; Altomare, Corrado MD4; Yoshida, Yuki MS4; Zhu, Julie MD4; Schaffer, Sam MD5; Soulban, Graziella PhD5

doi: 10.1097/GME.0000000000001350
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Objective: To prospectively evaluate the effects of ospemifene on the vulva and vagina in postmenopausal women using vulvar-vestibular photography and direct visual assessments.

Methods: Postmenopausal women (aged 40-80 years) with moderate to severe vaginal dryness as their most bothersome symptom (MBS) were randomized to daily ospemifene 60 mg or placebo in this 12-week, multicenter, double-blind, phase 3 study. Vulvar-vestibular photographic images were captured at baseline and week 12 and were independently assessed with the Vulvar Imaging Assessment Scale (VIAS). Changes from baseline in Vaginal and Vulvar Health Indices (VHI and VuHI) with ospemifene versus placebo were analyzed at weeks 4, 8, and 12. Correlations between VIAS, VHI, and VuHI, with vaginal dryness severity and the Female Sexual Function Index (FSFI) scores were also assessed.

Results: In all, 631 eligible participants were randomized (ospemifene 316, placebo 315) and included in the intention-to-treat population. Compared with placebo, ospemifene significantly improved total scores for VIAS (P = 0.0154), VHI (P < 0.0001), and VuHI (P < 0.0001) from baseline to week 12; significant VHI (P < 0.0001) and VuHI (P = 0.002) improvements were observed at week 4. Most VHI and VuHI individual items were significantly better with ospemifene versus placebo at week 12 (P < 0.05). Most correlations between the vulvovaginal assessment total scores versus vaginal dryness severity and FSFI scores were significant (P < 0.05).

Conclusion: Improvements observed in vulvovaginal health with ospemifene assessed by prospective vulvar-vestibular photography and other direct visual assessments support its efficacy in addition to the treatment of moderate to severe vaginal dryness due to menopause and the use of photographic and direct visual evaluations in future clinical trials.

This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

Video Summary Supplemental Digital Content 1, http://links.lww.com/MENO/A415

This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

1Director, Sexual Medicine, Alvarado Hospital, San Diego, CA

2George Washington University, School of Medicine, IntimMedicine Specialists, Washington, DC

3University of Florida, College of Medicine-Jacksonville, Jacksonville, FL

4Shionogi Inc, Florham Park, NJ

5Duchesnay Inc, Quebec, Canada.

Address correspondence to: Irwin Goldstein, MD, San Diego Sexual Medicine, 5555 Reservoir Drive, Suite 300, San Diego, CA 92120. E-mail: dr.irwingoldstein@gmail.com

Received 30 November, 2018

Revised 5 March, 2019

Accepted 5 March, 2019

Data presentation: Presented at The North American Menopause Society annual meeting, October 3 to 6, 2018, San Diego, CA.

Funding/support: This study was sponsored by Shionogi Inc. and Duchesnay Inc. Medical writing support was provided by Shilpa Lalchandani, PhD, and Kathleen Ohleth, PhD, of Precise Publications, LLC and was funded by Duchesnay Inc.

Financial disclosure/conflicts of interest: Dr Goldstein has received research support from AMAG Pharmaceuticals, Endoceutics, Ipsen, Strategic Science & Technologies, and Valeant; has received fees for consulting/advisory boards from Duchesnay Inc, Ipsen, Shionogi Inc, Sprout, and Strategic Science & Technologies; and is on the speakers bureau of AMAG Pharmaceuticals, Deka, and Duchesnay Inc. Dr. Simon has served (within the past year or current) as consultant/advisor to AbbVie, Allergan plc, AMAG, Amgen, Ascend Therapeutics, Bayer Healthcare, CEEK Enterprises, Covance, Dare Bioscience, Duchesnay, Hologic, KaNDy/NeRRe Therapeutics, Mitsubishi Tanage, ObsEva SA, Palatin Technologies, Sanofi SA, Shionogi, Sprout, and TherapeuticsMD; has received (within the past year or current) grant/research support from AbbVie, Agile Therapeutics, Allergan plc, Bayer Healthcare, Endocuetics, GTx, Ipsen, Myovant Sciences, New England Research Institute, ObsEva SA, Palatin Technologies, Symbio Research, TherapeuticsMD, and Viveve Medical; has served (within the past year or current) on the speaker's bureaus of AbbVie, AMAG, Duchesnay, Novo Nordisk, Shionogi, and TherapeuticsMD; and is a stockholder (direct purchase) in Sermonix. Dr. Kaunitz has served (within the past three years or current) as a consultant to or on the advisory boards of Allergan, AMAG, Mithra, Pfizer; and Shionogi and has received research support (to University of FL) from Bayer Healthcare, Endoceutics and TherapeuticsMD. Dr. Altomare and Yuki Yoshida are employees of Shionogi, and Dr. Zhu was an employee of Shionogi at the time of the study. Drs. Schaffer and Soulban are employees of Duchesnay Inc.

Supplemental digital content is available for this article. DirectURL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.menopause.org).

© 2019 by The North American Menopause Society.