What is the mechanism of action of this treatment?

Common treatments for women at risk for pregnancy include intrauterine devices (IUDs) like VeraCept™ and ParaGard®, which create an inhospitable environment for sperm, preventing fertilization or implantation. This is particularly important for women seeking long-term, reliable contraception. Hormonal contraceptives, another common option, work by preventing ovulation and thickening cervical mucus to block sperm. Barrier methods, such as condoms, physically prevent sperm from reaching the egg. These mechanisms are essential for providing effective and varied contraceptive options to meet individual needs and preferences.

What side effects are associated with this type of intervention?

Intrauterine devices (IUDs) like VeraCept™ and ParaGard® are commonly used for contraception. The known side effects of IUDs include cramping and discomfort during insertion, irregular bleeding or spotting, and heavier menstrual periods, particularly with copper IUDs like ParaGard®. There is also a small risk of the IUD expelling itself from the uterus, and in rare cases, it can perforate the uterine wall. Hormonal IUDs may cause side effects such as mood changes, acne, headaches, and breast tenderness. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several intrauterine devices (IUDs) for preventing pregnancy by creating an inhospitable environment for sperm. Notable examples include ParaGard®, a copper IUD that releases copper ions toxic to sperm, and hormonal IUDs like Mirena® and Skyla®, which release levonorgestrel to thicken cervical mucus and inhibit sperm movement. These methods are effective in preventing fertilization or implantation, similar to the mechanism being studied for VeraCept™ IUD.

What other types of research exist?

Promising alternatives to VeraCept™ IUD for women at risk for pregnancy include: 1) ParaGard® IUD, a non-hormonal copper IUD that creates an inhospitable environment for sperm. 2) Levonorgestrel-releasing intrauterine systems (LNG-IUS), which release hormones to prevent fertilization and implantation. 3) Bioself 110, an electronic fertility indicator that combines basal body temperature and calendar methods for effective family planning. 4) Etonogestrel contraceptive implant, a long-acting reversible contraceptive that releases hormones to prevent pregnancy.

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Intrauterine Device

VeraCept vs. ParaGard IUDs for Pregnancy Prevention (IUD Trial)

Phase 3

Waitlist Available

Research Sponsored by Sebela Pharmaceuticals Inc.

Eligibility Criteria Checklist

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

Must have

Sexually active with a male partner who has not had a vasectomy

Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed consent/assent and in good general health

Must not have

Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 60 months of study participation

Concurrent use of corticosteroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at year 3 and year 5 as determined by pk samples drawn at each visit

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial compares two methods of birth control in healthy women who have started menstruating. One method may use hormones or a physical barrier, while the other uses copper to prevent pregnancy.

Who is the study for?

This trial is for post-menarcheal, pre-menopausal women up to age 45 who are sexually active with a male partner and not using other contraception. They must have regular menstrual cycles, be willing to risk pregnancy, and stay near the research site during the study. Women can't join if they're pregnant or at risk of pregnancy from recent unprotected sex, breastfeeding without menstruation return, have certain uterine conditions or cancer history, HIV/AIDS, drug abuse within last year or intolerance to IUD materials.

What is being tested?

The trial compares two types of intrauterine devices (IUDs) for birth control: VeraCept and ParaGard. It aims to assess how these IUDs distribute in the body over time (pharmacokinetics) among healthy women seeking contraception.

What are the potential side effects?

Potential side effects may include discomfort during insertion, cramping or backaches shortly after placement, heavier menstrual periods and spotting between periods especially in the first few months for ParaGard users; exact side effects for VeraCept are being studied but could be similar.

Eligibility Criteria

Inclusion Criteria

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

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I am sexually active with a man who is not sterilized.

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I am a woman under 45, have started menstruating, and am in good health.

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I agree to use only the study drug for birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I plan to use hormone treatments other than contraceptives during the study.

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I am currently taking corticosteroids.

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I have had a pregnancy-related tumor, with or without high ß-hCG levels.

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I may have cervical, uterine, or ovarian cancer, or I have an abnormal Pap smear needing further evaluation.

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I have not had untreated cervicitis or vaginitis in the last 3 months.

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I have HIV/AIDS.

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I have a uterine condition that could affect medication placement.

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I experience very heavy or painful periods.

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I have had unusual bleeding from my uterus that cannot be explained.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at year 3 and year 5 as determined by pk samples drawn at each visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at year 3 and year 5 as determined by pk samples drawn at each visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and at year 3 and year 5 as determined by pk samples drawn at each visit for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Observed systemic copper bioavailability of VeraCept vs. ParaGard

Secondary study objectives

Baseline-corrected total serum copper of VeraCept vs. ParaGard

Compare total serum copper levels of VeraCept vs. ParaGard compared to normal copper levels

Long-term stability of copper levels as determined by Cmax - VeraCept only

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VeraCeptExperimental Treatment1 Intervention

VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years

Group II: ParaGardActive Control1 Intervention

ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VeraCept

2015

Completed Phase 2

~290

0 / 12Eligibility 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 treatments for women at risk for pregnancy include intrauterine devices (IUDs) like VeraCept™ and ParaGard®, which create an inhospitable environment for sperm, preventing fertilization or implantation. This is particularly important for women seeking long-term, reliable contraception. Hormonal contraceptives, another common option, work by preventing ovulation and thickening cervical mucus to block sperm. Barrier methods, such as condoms, physically prevent sperm from reaching the egg. These mechanisms are essential for providing effective and varied contraceptive options to meet individual needs and preferences.

Acceptability of a Long-Acting, Multipurpose Vaginal Ring: Findings from a Phase I Trial in the U.S. and Dominican Republic.Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC): meta-analysis of individual participant data from randomised controlled trials.Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology.