Nonhormonal Contraceptive Ring for Birth Control

Overseen By Lauren Dawson, BS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: IVR

Disqualifiers: Pregnancy, Gynecological abnormalities, STIs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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

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.

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

Group I: Placebo IVR Experimental Treatment 1 Intervention

Participants will use a placebo IVR for 14 days.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contraceptive vaginal ring. Edwardson, J., Jamshidi, R.[2013]

The levonorgestrel-releasing intravaginal ring (IVR) was found to be generally well-accepted by 60.7% of women after 12 months of use, indicating good tolerance and acceptability as a contraceptive method.

The pregnancy rates were 5.1% at 12 months and 6.5% at 24 months, showing that the IVR has a failure rate comparable to other progestogen-only contraceptive methods, supporting its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial UK experience of the levonorgestrel-releasing contraceptive intravaginal ring. Sahota, J., Barnes, PM., Mansfield, E., et al.[2019]

Contraceptive vaginal rings (CVRs), such as NuvaRing and Progering, are effective contraceptive options that provide similar or slightly better effectiveness compared to the pill, with the added benefits of ease of use and better cycle control due to their constant hormone release.

While CVRs are generally safe and well-accepted by women, they may cause some side effects like vaginal discharge and discomfort during insertion, which are important considerations for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraceptive vaginal rings: a review. Brache, V., Faundes, A.[2010]

The contraceptive vaginal ring, which releases ethinyl estradiol and etonogestrel, has been shown to be as effective and safe as oral contraceptives, with users reporting higher satisfaction and fewer systemic side effects.

In addition to contraception, the vaginal ring can help manage menstrual symptoms and is being explored for delivering antiretroviral drugs for HIV protection, highlighting its versatility in women's health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal ring contraception. Kerns, J., Darney, P.[2014]

The contraceptive vaginal ring, such as NuvaRing®, provides effective birth control through continuous intravaginal delivery of both estrogen and progesterone, resulting in lower systemic hormone levels.

This method offers better cycle control compared to progesterone-only contraceptives and has a favorable safety and tolerability profile, making it highly acceptable to most users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the efficacy, safety, and patient acceptability of the combined contraceptive vaginal ring (NuvaRing). Wieder, DR., Pattimakiel, L.[2022]

The NuvaRing is a highly effective contraceptive method, with a Pearl Index of 0.65, indicating a low failure rate in preventing pregnancy among European women during clinical trials.

It provides a stable release of hormones, avoiding daily fluctuations seen with oral contraceptives, and is designed for 3 weeks of use followed by a 1-week break, making it a convenient option for women seeking hormonal contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combined contraceptive vaginal ring (NuvaRing): evaluation of the clinical and pharmacological evidence. Gruber, CJ.[2016]

Intravaginal rings (IVRs) are effective for delivering hormones directly to the target site, avoiding systemic side effects and the hepatic first-pass effect, which enhances drug absorption and reduces the risk of drug resistance.

The study highlights the potential of IVRs to improve treatments for conditions like contraception, endometriosis, and hormone deficiencies, while also addressing challenges such as controlling hormone release rates and production costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Hormonal Intravaginal Rings: Technology and Challenges. Rafiei, F., Tabesh, H., Farzad, S., et al.[2021]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Contraceptive vaginal ring containing segesterone acetate and ethinyl estradiol: long-acting, patient-controlled, procedure-free, reversible prescription birth control. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Intravaginal rings: controlled release systems for contraception and prevention of transmission of sexually transmitted infections. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The contraceptive vaginal ring. [2013]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Initial UK experience of the levonorgestrel-releasing contraceptive intravaginal ring. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Contraceptive vaginal rings: a review. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

Vaginal ring contraception. [2014]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Examining the efficacy, safety, and patient acceptability of the combined contraceptive vaginal ring (NuvaRing). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The combined contraceptive vaginal ring (NuvaRing): evaluation of the clinical and pharmacological evidence. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

Development of Hormonal Intravaginal Rings: Technology and Challenges. [2021]