Ovaprene for Birth Control

Recruiting at21 trial locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Daré Bioscience, Inc.

Must not be taking: Antibiotics, Antivirals

Disqualifiers: Pregnancy, Breastfeeding, HIV, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing Ovaprene, a ring placed inside the vagina to prevent pregnancy without hormones. It aims to see how well it works, how safe it is, and if women find it acceptable. The study focuses on women who want a non-hormonal birth control 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 data supports the effectiveness of the treatment Ovaprene for birth control?

The pilot study on the Ovaprene ring suggests it is being evaluated for safety and tolerability as a nonhormonal barrier contraceptive, which implies it may be effective in preventing pregnancy by physically blocking sperm. ^{1 2 3 4 5}

Is Ovaprene safe for use as a birth control method?

The research does not provide specific safety information about Ovaprene, but it discusses safety concerns related to oral contraceptives, such as cardiovascular risks and hormonal side effects. It's important to consult with a healthcare provider for personalized advice. ^{6 7 8 9 10}

How is the Ovaprene treatment different from other birth control options?

Ovaprene is unique because it is a nonhormonal vaginal contraceptive ring, unlike many other birth control methods that rely on hormones. This makes it a novel option for those who prefer or require nonhormonal contraception. ^{1 3 11 12 13}

Research Team

Christine Mauck, MD

Principal Investigator

Daré Bioscience, Inc.

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Ovaprene (Barrier Method)

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.

Participant Groups

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+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

A pilot safety and tolerability study of a nonhormonal vaginal contraceptive ring. [2015]

2. Germany 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. [2018]

3. United States 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. [2022]

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

European Society of Contraception oral contraceptives survey update: birth control methods in "Europe of the 12". [2015]

5. England 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. [2013]

6. France pubmed.ncbi.nlm.nih.gov

[Side effects of third generation progestins]. [2013]

7. United States 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. [2022]

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

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

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

Oral contraceptives. [2017]

10. United States 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. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Considerations for the use of progestin-only contraceptives. [2022]

13. Kenya pubmed.ncbi.nlm.nih.gov

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