20 Participants Needed

Nonhormonal Contraceptive Ring for Birth Control

KV
LD
Overseen ByLauren Dawson, BS
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: The University of Texas Medical Branch, Galveston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I can communicate in English.
I am a female, born female.
Provide written informed consent
See 2 more

Exclusion Criteria

I have not had any major gynecologic or genital procedures in the last 21 days, except for colposcopy, cervical biopsies, or IUD removal.
Current use of an IVR (e.g., Nuvaring)
I have had a hysterectomy.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a placebo intravaginal ring (IVR) for 14 days to evaluate safety and acceptability

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

  • Placebo intravaginal ring (IVR)
Trial Overview The study is testing the safety and how acceptable women find using a placebo version of a new vaginal ring designed for contraception without hormones. It's an early-stage trial to ensure the device is user-friendly before it moves on to more advanced trials.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Placebo IVRExperimental Treatment1 Intervention
Participants will use a placebo IVR for 14 days.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials
263
Recruited
55,400+

Mucommune, LLC.

Collaborator

Trials
1
Recruited
20+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Findings from Research

The FDA approved Annovera, a contraceptive vaginal ring that can be used for a year, which releases hormones segesterone acetate and ethinyl estradiol, providing 97.5% effectiveness in preventing pregnancy.
While the side effects of Annovera are similar to other hormonal contraceptives, there is a noted increased risk of venous thromboembolism, prompting the FDA to require further studies to assess this risk.
Contraceptive vaginal ring containing segesterone acetate and ethinyl estradiol: long-acting, patient-controlled, procedure-free, reversible prescription birth control.Paton, DM.[2019]
Intravaginal rings (IVRs) are effective for delivering contraceptives and other medications over extended periods, improving compliance and providing benefits like cycle control and symptom relief for conditions such as menorrhagia and polycystic ovarian syndrome.
IVRs are being researched for their potential to deliver antibodies and microbicides, such as dapivirine and tenofovir, to prevent HIV-1 transmission, indicating their versatility in both contraceptive and preventive health applications.
Intravaginal rings: controlled release systems for contraception and prevention of transmission of sexually transmitted infections.Friend, DR.[2018]
The NuvaRing, a contraceptive vaginal ring containing etonogestrel and ethinyl estradiol, is effective for contraception, requiring only monthly administration and providing low hormone doses, which helps inhibit ovulation.
Most women using NuvaRing report positive effects on their bleeding profiles and overall satisfaction, with common side effects being mild and serious adverse events being rare.
The contraceptive vaginal ring.Edwardson, J., Jamshidi, R.[2013]

References

Contraceptive vaginal ring containing segesterone acetate and ethinyl estradiol: long-acting, patient-controlled, procedure-free, reversible prescription birth control. [2019]
Intravaginal rings: controlled release systems for contraception and prevention of transmission of sexually transmitted infections. [2018]
The contraceptive vaginal ring. [2013]
Initial UK experience of the levonorgestrel-releasing contraceptive intravaginal ring. [2019]
Contraceptive vaginal rings: a review. [2010]
Vaginal ring contraception. [2014]
Examining the efficacy, safety, and patient acceptability of the combined contraceptive vaginal ring (NuvaRing). [2022]
The combined contraceptive vaginal ring (NuvaRing): evaluation of the clinical and pharmacological evidence. [2016]
Development of Hormonal Intravaginal Rings: Technology and Challenges. [2021]
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