Nonhormonal Contraceptive Ring for Birth Control
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot currently use an intravaginal ring (IVR) like Nuvaring.
Is the nonhormonal contraceptive ring generally safe for humans?
The contraceptive vaginal rings, including those releasing hormones like etonogestrel and ethinyl estradiol, are generally considered safe, with common side effects such as headaches, vaginal discharge, and discomfort. Serious adverse events are rare, but there is a noted risk of venous thromboembolism (blood clots) with some hormonal rings, prompting further study by the FDA.12345
How does the placebo intravaginal ring differ from other contraceptive treatments?
The placebo intravaginal ring is unique because it does not contain active hormones, unlike other contraceptive rings that release hormones to prevent pregnancy. This makes it different from hormonal contraceptive options like the NuvaRing, which releases estrogen and progesterone to control the menstrual cycle and prevent ovulation.26789
What is the purpose of this trial?
In order to deliver nonhormonal vaginal contraceptive using anti-sperm antibodies, a new vaginal ring design using a capsule-IVR will be utilized. Evaluating the safety and acceptability of this device early in the product development cycle is important, not only because device/formulation characteristics become increasingly difficult to alter as product is advanced into clinical trials, but also because user adherence can directly impact clinical trial outcomes.
Eligibility Criteria
This trial is for healthy women interested in a new type of nonhormonal contraceptive. Participants should be willing to try an intravaginal ring (IVR) that releases antibodies against sperm. Specific eligibility criteria are not provided, but typically include age range and sexual activity status.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use a placebo intravaginal ring (IVR) for 14 days to evaluate safety and acceptability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo intravaginal ring (IVR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
Mucommune, LLC.
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator