Aresus announces presentation of clincial data for the treatment of female sexual pain with sinecatechins ointment
Strausberg, Germany, 21 July 2022
Aresus Pharma GmbH, a subsidiary of DERMAGO GmbH, announced today that clinical results on the efficacy of 5-10% Topical Sinecatechins (synonyms: “Polyphenon® E“, ”defined extract from green tea leaves“) Ointment for Postmenopausal Vestibulodynia1 were presented at the 2nd Congress on Women’s Health Innovations & Inventions in Tel Aviv on July 11-12th, 2022. Additionally, the poster had previously been presented at the North American Menopause Annual Meeting in Washington, D.C. in December 2021 and at the International Society for the Study of Women’s Sexual Health Annual Meeting in Dallas, Texas in March 2022.
The research was performed by a clinical team under the lead of Dr. Lila Nachtigall, Professor of Obstetrics and Gynecology at New York University School of Medicine.
In the randomized, double-blind, placebo-controlled trial, 32 postmenopausal sexually active women with significant to severe secondary provoked vestibulodynia were enrolled. The authors concluded that topical 5% sinecatechins ointment applied once daily or 10% sinecatechins ointment applied three times a week significantly reduced provoked secondary vestibulodynia in postmenopausal women without having a proliferating effect on the vaginal epithelium.
The funds for the study were provided by GTO Pharmaceutical, LLC (GTO). GTO Pharmaceutical, LLC and Aresus Pharma GmbH are evaluating the further development and commercialization strategy for the use of sinecatechins ointment in vestibulodynia.
Dr. Wendy (Keller) Epstein, CEO of GTO Pharmaceutical, LLC. and, Adjunct Assistant Professor of Dermatology at New York University School of Medicine comments:
“A large proportion of postmenopausal women need access to an effective non-hormonal topical drug that alleviates vestibulodynia, the most common cause of sexual pain. Sinecatechins ointment fulfils this unmet medical need because it can be used by women with or without a history of estrogen sensitive malignancies.
Although requiring further study, researchers reported that several women noted an increase in lubrication, sexual arousal and/or decreased latency to orgasm, a finding consistent with the known neurobiology of female sexual pain and arousal “.
Vestibulodynia is chronic pain and discomfort that occurs in the area around the opening of the vagina, inside the inner lips of the vulva. This area is known as the vestibule. The pain may occur when the area is touched, when a tampon is used, during sexual intercourse, during a pelvic exam, when tight clothes are worn, or even when sitting for a long time. In some cases the area may also be red and inflamed. Vestibulodynia is a specific type or localized form of vulvodynia, chronic pain of the vulva.2 It is estimated that at least 16% of women in the United States are affected by vestibulodynia.3
1 Nachtigall L, et al Efficacy of 5-10% Topical Sinecatechins Ointment for Postmenopausal Vestibulodynia. Menopause Vol 28 No. 12 2021 pp 1467
2 Vestibulodynia – What Is Vestibulodynia? Baylor Medicine (last access: 20.07.2022) https://www.bcm.edu/healthcare/specialties/obstetrics-and-gynecology/ob-gyn-conditions/vestibulodynia
3 The causes and prevalence of vestibulodynia: a vulvar pain disorder, Feldhaus-Dahir, M. Urol Nur . Jan-Feb 2011;31(1):51-4.
Shahrahmani H, Kariman N, Jannesari S, et al. The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized,double‐blind, placebo‐controlled clinical trial. Phytotherapy
phone: ++49 (0) 3341-589 90 40