Clinical study with VagiVital® shows significant symptom relief in women undergoing cancer treatment and suffering from vaginal atrophy
Stockholm September 3, 2020 - Peptonic Medical (publ) (‘Peptonic’ or ‘the Company’) informs about the results of the latest clinical study with VagiVital®. The objective of this study was to investigate whether, and to what extent, VagiVital® can relieve symptoms associated with vaginal atrophy in women taking aromatase inhibitors (antiestrogens) as part of their cancer treatment.
The results show strong relief of the most bothersome symptoms such as vaginal dryness, vaginal itching and pain during sexual intercourse (dyspareunia). In addition, vaginal pH decreased as a result of treatment with VagiVital®. All improvements were statistically significant (p<0.001) and the magnitude of the improvements were at least on the same level as seen in previous clinical studies with VagiVital®.
- The study was conducted on a group of women with, in many cases, severe symptoms due to their medication and it feels good to be able to offer a hormone-free symptom relief with clinically proven effect to this group. We are pleased to be able to confirm the symptom relieving effect of VagiVital® in vaginal atrophy patients in yet another clinical study, says Johan Inborr, CEO of Peptonic Medical.
The study was conducted at Karolinska University Hospital and lasted for 12 weeks with a 2-week follow-up. The study patient population consisted of 32 women aged 40 to 82 years, all of whom had been treated for hormone-dependent cancer and were on treatment with aromatase inhibitors, and suffered from symptoms of vaginal atrophy. These women are contraindicated for estrogens and other hormones.The study primarily measured the change in the severity of the specific symptom of vaginal atrophy that each patient experienced as most bothersome by way of self-assessment. The symptoms associated with vaginal atrophy that were measured included dyspareunia (pain during sexual intercourse), vaginal dryness, vaginal irritation and itching and dysuria (pain when urinating). As a second and objective endpoint, the change in vaginal pH was measured. Patients were treated with one dose of VagiVital® per day for 12 weeks.
For more information, please contact;
Johan Inborr, CEO
Mobile: +46 708 853 893
E-mail: johan.inborr@peptonicmedical.se
This information is information that Peptonic Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 3rd September, 2020.
About VagiVital®
VagiVital® is a patent pending hormone free self-care product for the treatment of vaginal atrophy and vaginal dryness. The product has been tested in randomised clinical studies (vaginal atrophy) with very positive results both for objective (vaginal pH and proportion of superficial cells in the vaginal mucosa) and subjective (most bothersome symptoms, such as vaginal dryness, vaginal irritation/itching, dyspareunia and dysuria) parameters. The magnitude of symptom relief is on par with that demonstrated with e.g. prescription estrogen based products on the market today. It was very well tolerated and caused no serious adverse effects.
VagiVital® was launched in Sweden as a non-prescription self-care product in July 2018 (see www.vagivital.com).
About Peptonic Medical
Peptonic Medical is an innovative Swedish medical development company. Its vision is to offer safe and effective treatments and relief for women specific diseases and medical conditions.
VagiVital® is a registered trademark of Peptonic Medical. The product is hormone free and is being commercialised for the non-prescription use for the treatment of vaginal atrophy (VA) and vaginal dryness. The pipeline of Peptonic Medical also includes Vagitocin®, which is an oxytocin-based vaginal gel for the treatment of VA. This product candidate is in clinical development phase 2. The development of Vagitocin® is on hold pending additional data on i.a. the mechanism of action.
Since July 2014, the Peptonic Medical share has been traded on the Spotlight Stock Exchange (www.spotlightstockmarket.se, ticker: PMED) in Stockholm, Sweden.
For more information: www.peptonicmedical.com
