Ovaprene for Birth Control

Recruiting at 19 trial locations

Overseen By Alison Edelman, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Daré Bioscience, Inc.

Must not be taking: Antibiotics, Antivirals

Disqualifiers: Pregnancy, Breastfeeding, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

656 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new non-hormonal birth control device called Ovaprene, an intravaginal ring. The researchers aim to evaluate its effectiveness, safety, and user satisfaction as a contraceptive method. Sexually active individuals, assigned female at birth, who are in good health, not currently pregnant, and seeking non-hormonal contraception, are eligible to participate. Participants should not wish to become pregnant for at least 13 months and must have regular menstrual cycles. They must agree to use Ovaprene as their sole form of birth control during the study. As an unphased trial, this study offers a unique opportunity to contribute to the development of a new contraceptive option.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you must stop your current method of contraception (except condoms) before starting Ovaprene.

What prior data suggests that this intravaginal ring is safe for birth control?

Research has shown that Ovaprene is generally safe as a contraceptive. In one study, researchers found no new safety concerns. Approximately 17% of participants stopped using it due to vaginal odor, the most common reason for discontinuation. Additionally, Ovaprene did not cause irritation or harm to the vaginal area or its natural bacteria. These findings suggest that most users tolerate Ovaprene well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ovaprene is unique because, unlike typical hormonal birth control methods such as pills, patches, or injections, it is a non-hormonal, barrier contraceptive device. This means it doesn't rely on hormones to prevent pregnancy, which can be beneficial for those who experience unwanted side effects from hormonal options. Ovaprene is inserted into the vagina and works by blocking sperm passage and releasing a spermiostatic agent to immobilize sperm, offering a new approach that can appeal to those seeking hormone-free birth control. Researchers are excited about this treatment as it potentially provides a safe, convenient, and reversible method of contraception without the hormonal side effects.

What evidence suggests that Ovaprene is effective for birth control?

Research has shown that Ovaprene, a non-hormonal vaginal ring, could serve as an effective birth control method. Studies have found it works about 86% to 91% of the time with typical use over six months, similar to diaphragms. Ovaprene reduces the number of active sperm reaching the cervical mucus, which is crucial for preventing pregnancy. These findings suggest that Ovaprene could be a reliable non-hormonal birth control option. ^{1 2 3 6 7}

Who Is on the Research Team?

Christine Mauck, MD

Principal Investigator

Daré Bioscience, Inc.

Are You a Good Fit for This Trial?

This trial is for sexually active individuals assigned female at birth, aged 18-40, in good health and not wanting pregnancy for at least 13 months. They must be willing to use Ovaprene as their only birth control method during the study and have regular menstrual cycles. Partners should be male, over 18, and not known to be subfertile.

Inclusion Criteria

I am sexually active, can become pregnant, and want birth control.

I agree to use only Ovaprene for birth control during the study.

Are willing to stop using their current birth control method (except for condoms) before the second visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Ovaprene intravaginal ring to assess contraceptive effectiveness, safety, and acceptability

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ovaprene

Trial Overview The study tests Ovaprene's effectiveness as a non-hormonal contraceptive. Participants will use this intravaginal ring exclusively for birth control. The trial is open-label and conducted across multiple centers to assess safety and acceptability.

How Is the Trial Designed?

Group I: Ovaprene Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Daré Bioscience, Inc.

Lead Sponsor

Trials

11

Recruited

1,600+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The Ovaprene ring, tested in a pilot study with 20 women, was found to be safe and well-tolerated, with no reports of pain, bleeding, or serious adverse effects during its use.

Postcoital testing indicated that the Ovaprene ring effectively prevented sperm viability, suggesting its potential as a reliable barrier contraceptive method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot safety and tolerability study of a nonhormonal vaginal contraceptive ring. Del Priore, G., Malanowska-Stega, J., Shalaby, SW., et al.[2015]

Honduran women using the contraceptive mini-pill Ovrette were not provided with written information about the drug, raising concerns about informed consent and safety.

Ovrette, which contains the progestagen Norgestrel, is contraindicated for lactating women due to potential harmful effects on breastfed infants, and there are significant concerns about its long-term impact on children exposed to it, as highlighted by the WHO and US Pharmacopeia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Honduran women received no written information on contraceptive pill. [2003]

Progestin-only contraceptives (POCs) like pills, injections, IUDs, and implants are effective first-line options for preventing unwanted pregnancies, offering various advantages and disadvantages that need to be communicated to users.

Clinicians play a crucial role in ensuring women are well-informed about potential side effects and benefits of POCs, which can enhance adherence and reduce the likelihood of discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for the use of progestin-only contraceptives. Freeman, S., Shulman, LP.[2022]

Oral contraceptives (OCs) can have side effects related to the steroid dose and the balance of estrogen and progestin, which can affect cardiovascular health, particularly due to the estrogen component and certain progestins with androgenic properties.

New 'third generation' progestins have been developed to minimize adverse drug reactions and improve lipid profiles, showing promise in maintaining beneficial estrogenic effects while reducing cardiovascular risks associated with older formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Side effects of third generation progestins]. Sitruk-Ware, R.[2013]

The combined oral contraceptive (COC) containing estradiol valerate and dienogest demonstrated effective contraception with a Pearl Index of 1.64 over 13 cycles, indicating a low rate of on-treatment pregnancies among 490 women aged 18-35.

Safety data revealed that 51.8% of participants experienced treatment-related adverse events, with 14.9% discontinuing the study due to these events, highlighting the importance of monitoring side effects in contraceptive use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a combined oral contraceptive containing estradiol valerate/dienogest: results from a clinical study conducted in North America. Nelson, A., Parke, S., Mellinger, U., et al.[2022]

Third generation oral contraceptives (OCs) were associated with significantly higher levels of C-reactive protein (CRP) in a study of 128 women, indicating a potential increase in cardiovascular risk.

The study found that triglyceride levels were the main factor influencing CRP levels in women using OCs, suggesting that monitoring lipid levels may be important for assessing cardiovascular risk in these users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of second and third generation oral contraceptives on C-reactive protein, lipids and apolipoproteins in young, non-obese, non-smoking apparently healthy women. Krintus, M., Sypniewska, G., Kuligowska-Prusinska, M.[2019]

In a study involving 983 women over 13 cycles, NuvaRing demonstrated a lower pregnancy rate (Pearl Index of 0.25) compared to a combined oral contraceptive (COC) which had a Pearl Index of 0.99, indicating that NuvaRing may be more effective in preventing pregnancy.

Both NuvaRing and COC showed high compliance and user satisfaction, with 96% of women finding NuvaRing easy to insert and remove, while tolerability was similar, with fewer estrogen-related side effects reported for NuvaRing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 microg of ethinyl estradiol and 3 mg of drospirenone. Ahrendt, HJ., Nisand, I., Bastianelli, C., et al.[2022]

In a study of 2419 healthy women, oral contraceptives containing gestodene provided better cycle control than those containing desogestrel, particularly reducing breakthrough bleeding and spotting significantly during the first several cycles.

All three contraceptive treatments were well tolerated, with similar rates of adverse events across groups, although desogestrel was associated with a higher incidence of metrorrhagia compared to gestodene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of cycle control and effect on well-being of monophasic gestodene-, triphasic gestodene- and monophasic desogestrel-containing oral contraceptives. Gestodene Study Group. Bruni, V., Croxatto, H., De La Cruz, J., et al.[2013]

The FDA has heavily relied on epidemiologic studies to regulate oral contraceptives, using findings to inform labeling and safety communications, which has influenced usage patterns, including a decline in overall use and a shift to lower steroid formulations.

Future studies are planned to better understand the effects of different progestins on cardiovascular risks and potential links to cancers, which could further impact regulatory decisions and guidelines for oral contraceptive use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of epidemiology in the regulation of oral contraceptives. Sobel, S.[2018]

A randomized controlled trial involving postpartum women showed that starting the progestin-only contraceptive Ovrette at six weeks postpartum is as effective as starting it at the return of menses or six months postpartum, with no pregnancies reported in either group during the 18-month follow-up.

There were no significant differences in continuation rates of the contraceptive between the two initiation timing groups, indicating that both options are safe and effective for breastfeeding women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial to determine optimum initiation time of norgestrel-progestin only contraception in Eldoret Teaching Hospital, Kenya. Were, EO., Kendall, JZ., Nyongesa, P.[2013]

New multiphasic oral contraceptives (OCs) with 35 micrograms of ethinyl estradiol and 0.5-1.0 mg of norethindrone offer a balance of high effectiveness and safety, minimizing side effects for users.

Educating patients about potential adverse effects, such as breakthrough bleeding and the absence of withdrawal bleeding, enhances safety and reduces confusion, leading to better management of oral contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral contraceptives. Ellsworth, AJ., Leversee, JH.[2017]

In a study of 52 women with polycystic ovary syndrome (PCOS), combined oral contraceptives containing cyproterone acetate were found to be more effective than those with drospirenone in reducing clinical hirsutism after 12 months of treatment.

The group taking cyproterone acetate showed a significant decrease in the modified Ferriman-Gallwey (mFG) score, indicating improved hirsutism, while the drospirenone group had a greater reduction in waist-to-hip ratio, suggesting different benefits from each treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two oral contraceptive forms containing cyproterone acetate and drospirenone in the treatment of patients with polycystic ovary syndrome: a randomized clinical trial. Kahraman, K., Sükür, YE., Atabekoğlu, CS., et al.[2018]

A survey of 102 physicians across 12 European countries revealed that modern combined oral contraceptives (OCs) with low doses of ethinyl estradiol and various progestogens are the most commonly prescribed, primarily due to their tolerability.

Despite evidence showing no link between past OC use and cardiovascular disease, 42% of physicians still consider cardiovascular risks their main concern, leading to inconsistent prescribing practices that may limit access to OCs for many women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European Society of Contraception oral contraceptives survey update: birth control methods in "Europe of the 12". Serfaty, D., Wildemeersch, D., Verougstraete, A., et al.[2015]

Citations

1. ir.darebioscience.com ir.darebioscience.com/news-releases/news-release-details/positive-interim-phase-3-results-highlight-potential-ovaprener

Positive Interim Phase 3 Results Highlight Potential of ... At the time of the interim analysis, approximately 9% of the women treated in the study had experienced a pregnancy, a rate consistent with the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S001078242400012X

Successful postcoital testing of Ovaprene In comprehensive rigorous evaluation, use of Ovaprene resulted in a reduction in progressively motile sperm reaching midcycle cervical mucus consistent with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06127199

NCT06127199 | Contraceptive Efficacy Study of Ovaprene This will be a multi-center, single arm, open-label study of Ovaprene, a non-hormonal intravaginal ring, to investigate the contraceptive effectiveness, ...

4. contemporaryobgyn.net contemporaryobgyn.net/view/ovaprene-indicated-effective-for-non-hormonal-contraception

Ovaprene indicated effective for non-hormonal contraception A comprehensive investigation confirmed Ovaprene's non-hormonal design achieves consistent contraceptive efficacy.

5. drugdiscoverynews.com drugdiscoverynews.com/a-new-drug-device-combination-for-non-hormonal-contraception-16251

A new drug-device combination for non-hormonal ... In pregnancy rate studies, Ovaprene has had 86 to 91 percent contraceptive effectiveness with typical use at six months (3). That's the same range as diaphragms ...

6. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/ovaprene-phase-3-trial-shows-promise-as-novel-non-hormonal-contraceptive/

Ovaprene® Phase 3 Trial Shows Promise as Novel Non- ... An interim analysis by the Data Safety Monitoring Board recommended the study continue as planned, with a pregnancy rate of approximately 9%, ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38552818/

Safety testing of Ovaprene: An investigational ... Conclusions: Ovaprene use did not result in cervicovaginal irritation or adverse effects on resident vaginal microbiota and did not impact transitions from a ...