VeraCept IUD for Preventing Pregnancy

Not currently recruiting at 49 trial locations

Age: < 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Sebela Pharmaceuticals Inc.

Must not be taking: Hormonal contraceptives

Disqualifiers: Pregnancy, Cancer, HIV, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of VeraCept, a new intrauterine device (IUD), for preventing pregnancy. The study aims to gather data on the device's efficacy as a contraceptive option. Women with regular menstrual cycles, in a monogamous relationship, and seeking to avoid pregnancy for the study's duration might be suitable candidates. Participants should also agree to use VeraCept as their sole form of birth control during the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the availability of a new contraceptive option.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use any non-contraceptive estrogen, progesterone, or testosterone during the study.

What prior data suggests that the VeraCept IUD is safe for preventing pregnancy?

Research has shown that the VeraCept IUD is generally well-tolerated and effectively prevents pregnancy with fewer side effects. In a previous study, users reported experiencing fewer side effects compared to other copper IUDs, possibly due to VeraCept's smaller amount of copper, which may cause less irritation.

Previous users found the VeraCept IUD to be safe and effective, supporting its continued testing in further studies. While no treatment is entirely without risk, current data suggest that VeraCept is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

VeraCept is unique because it offers a new approach to preventing pregnancy using a non-hormonal, flexible IUD design. Unlike traditional hormonal IUDs, VeraCept provides contraception without the use of hormones, which can be appealing to those seeking to avoid hormonal side effects. Researchers are excited about its potential for being both effective and comfortable, as its soft, flexible frame is designed to fit a wider range of uterine shapes, improving user experience and potentially enhancing overall satisfaction.

What evidence suggests that VeraCept IUD is effective for preventing pregnancy?

Research has shown that the VeraCept IUD, which participants in this trial will receive, effectively prevents pregnancy. One study found the chance of pregnancy was about 1% per year, similar to other copper IUDs. The 1-year Pearl Index, which measures effectiveness, was 0.94, indicating a very low chance of pregnancy. Nearly all participants had the IUD placed successfully, and both doctors and users reported positive experiences. Early results suggest that VeraCept is a dependable birth control option. ^{1 4 6 7 8}

Who Is on the Research Team?

David Turok, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women up to 45 years old who are sexually active, have regular menstrual cycles, and want to avoid pregnancy using the VeraCept IUD as their only contraceptive method. They must be in good health, not planning on moving away from the study area, and willing to risk pregnancy. Women with heavy bleeding, uterine abnormalities, or certain medical conditions like HIV or untreated infections cannot join.

Inclusion Criteria

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

Subject agrees not to self-remove VeraCept

Plan to reside within a reasonable driving distance of a research site for the duration of the study

Exclusion Criteria

Known or suspected alcohol or drug abuse within 12 months prior to the screening visit

I've used Depo-Provera in the last 10 months and haven't had 2 normal periods since.

I have a uterine condition that could affect medication placement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VeraCept intrauterine contraceptive for contraceptive efficacy, safety, and tolerability assessment

3 years

Visit 1 (Day 1) for VeraCept placement

Extension

Participants may continue using VeraCept for up to 8 years to assess long-term contraceptive efficacy and safety

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• VeraCept

Trial Overview The trial is testing the effectiveness of a new intrauterine device (IUD) called VeraCept in preventing pregnancy. Participants will use this IUD as their sole form of birth control and track its performance over time through various tests and follow-ups.

How Is the Trial Designed?

Group I: VeraCept Experimental Treatment 1 Intervention

VeraCept® Intrauterine Contraceptive

Who Is Running the Clinical Trial?

Sebela Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

4,100+

Sebela Women's Health Inc.

Lead Sponsor

Trials

6

Recruited

4,100+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Synteract, Inc.

Industry Sponsor

Trials

21

Recruited

5,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03785366

A PK Study Comparing VeraCept vs. ParaGard Intrauterine ... A Randomized, Single-Blind, Comparative Bioavailability Study to Assess the Pharmacokinetic Properties of VeraCept® Intrauterine Contraceptive vs ParaGard® ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7098438/

Efficacy, Safety, and Tolerability of a New Low-Dose Copper ... Continuing to 36 months, the phase 2 study of a low-dose copper intrauterine device with a nitinol frame showed high efficacy and safety.

3. contraceptionjournal.org contraceptionjournal.org/article/S0010-7824(18)30334-2/fulltext

Phase 2 efficacy, safety and tolerability results of the ... Placement was successful in 283 subjects (98.9%). Participants reported a mean pain score at insertion of 1.44. There were no uterine perforations, four ...

4. sebelapharma.com sebelapharma.com/assets/media/FINAL51523ACOGDataPressRelease.pdf

Sebela Women's Health Announces Positive Phase 3 Data ... Both clinicians and study participants also reported positive experiences with placement of the IUD, with an overall placement success rate 98.8 ...

5. prnewswire.com prnewswire.com/news-releases/sebela-womens-health-announces-publication-of-phase-3-pivotal-study-results-for-the-investigational-copper-175-mm2-intrauterine-device-iud-in-contraception-302359611.html

Sebela Women's Health Announces Publication of Phase ... The pregnancy risk was about 1% per year, consistent with copper IUDs. The 1-year Pearl Index was 0.94 (95%CI 0.43-1.78) and the 3-year ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02167763

Comparative Study of the VeraCept Low-Dose Intrauterine ... The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low Dose Intrauterine Copper Contraceptive compared to the standard T ...

7. sebelapharma.com sebelapharma.com/long-acting-reversible-contraception

Long-Acting Reversible Contraception (LARC) Clinical trials remain ongoing to evaluate efficacy and safety for up to 8 years of use. 5-7. 52 mg Levonorgestrel IUD. We understand that many women who are ...

8. nature.com nature.com/articles/s44294-024-00026-y

the quest for materials for next-generation, non-hormonal ... A drop in side effects was reported for the flexible VeraCept Cu-IUD, likely due to its smaller Cu surface area, generating a smaller ...