What side effects are associated with this type of intervention?

Non-hormonal birth control methods, such as the copper intrauterine device (IUD) and barrier methods like diaphragms and condoms, are generally well-tolerated but can have some side effects. The copper IUD may cause heavier menstrual bleeding and cramping, especially in the first few months after insertion. Barrier methods can sometimes cause irritation or allergic reactions due to latex or spermicides. Non-hormonal intravaginal rings like Ovaprene, which act as physical barriers or alter the vaginal environment, may cause vaginal irritation or discomfort. It is important to discuss these potential side effects with a healthcare provider to determine the most suitable contraceptive method.

What prior FDA approvals exist?

Historically, the FDA has approved various contraceptives, including non-hormonal methods like copper IUDs (e.g., ParaGard) and hormonal methods such as combined estrogen-progestin oral contraceptives and hormonal IUDs. Non-hormonal intravaginal rings like Ovaprene, which act as a physical barrier to sperm or alter the vaginal environment to prevent fertilization, represent a newer category currently under investigation.

What other types of research exist?

Promising, novel alternatives to Ovaprene for birth control patients considering treatment in 2024 include: 1) Phexxi, a non-hormonal vaginal gel that maintains the vaginal pH to prevent sperm motility. 2) New developments in copper intrauterine devices (IUDs) which act as a physical barrier and alter the uterine environment to prevent fertilization. 3) Advances in male contraceptive methods, such as Vasalgel, a non-hormonal gel injected into the vas deferens to block sperm transport.

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Barrier Method

Ovaprene for Birth Control

N/A

Recruiting

Research Sponsored by Daré Bioscience, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sexually active people assigned female at birth, at risk for pregnancy and desiring contraception

Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days, without heavy bleeding that lasts longer than 5 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed here but may include typical reactions associated with intravaginal devices such as discomfort, discharge or infection risk due to foreign body presence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My menstrual cycles are regular, lasting 21 to 35 days without prolonged heavy bleeding.

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

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I am between 18 and 40 years old.

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I am 18 or older and not known to have fertility issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of pregnancy rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: OvapreneExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ovaprene

2018

N/A

~40

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common birth control treatments include hormonal methods like combined estrogen-progestin oral contraceptives, which suppress ovulation, thicken cervical mucus, and alter the endometrial lining to prevent implantation. Non-hormonal methods, such as the Ovaprene intravaginal ring, act as physical barriers to sperm or change the vaginal environment to prevent fertilization. These mechanisms are important for patients to understand as they help in selecting the most appropriate method based on individual health needs, preferences, and potential contraindications.

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