Chlamydia/Gonorrhea Prevention Clinical Trial
EVOGUARD is a double-blind, placebo-controlled Phase 3 clinical trial designed to assess the safety and efficacy of EVO100 vaginal gel to prevent Chlamydia trachomatis and Neisseria gonorrhea infection in women. Approximately 1,730 women who had a chlamydia or gonorrhea infection in the past 4 months will be enrolled at approximately 90 sites in the United States for a 4-month interventional period, followed by a 1-month follow-up period.
For more information, or to see if you qualify to take part in EVOGUARD
Expanded Access Program Policy
- Evofem understands that some patients may wish to access investigational medicinal products that are not yet approved by FDA. The most appropriate way for patients to access our investigational products is by participating in our ongoing clinical trial(s), which are managed by clinical experts and are designed to determine whether the investigational products are safe and effective. Furthermore, these clinical studies provide insight to the mechanism of action, safety, and efficacy of the investigational product so that the benefits and risks can be appropriately understood. The investigational new drug application process ensures treatment with the rigorous evaluation to ensure benefits outweigh the risks for the treatment of proposed use. Patients who are interested in participating in our ongoing studies are encouraged to discuss their specific needs with their healthcare provider.
- Information regarding our ongoing clinical trials can be accessed at www.clinicaltrials.gov
- Evofem understands that there may be patients interested in obtaining access to our investigational products for treatment under an Expanded Access Program, however, at this stage of development of our products, there is insufficient clinical data to support expanded access use for treatment of serious or life-threatening diseases or manufacture for this purpose. Hence Evofem does not currently provide access to our investigational products through expanded access.
- In accordance with the 21st Century Cures Act, this policy may be revised at any time and will be shared with the public on the Company sponsored website.
- If you have any additional questions, please reach out to your healthcare provider, fill out the form below or call 1-833 -383-6246 (833-EVFMBIO).