VeraCept vs. ParaGard IUDs for Pregnancy Prevention

(IUD Trial)

No longer recruiting at 1 trial location

Age: < 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Sebela Pharmaceuticals Inc.

Must not be taking: Corticosteroids, Estrogen, Progesterone, Testosterone

Disqualifiers: Pregnancy, Cancer, HIV, Uterine anomalies, 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: 59

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of intrauterine devices (IUDs), VeraCept and ParaGard, to evaluate their effectiveness in preventing pregnancy in healthy women who have started menstruating but are not yet menopausal. The researchers aim to understand how these contraceptives function in the body over time. Women with regular menstrual cycles, in a long-term, monogamous relationship with a male partner, may be suitable candidates if they wish to avoid pregnancy and use one of these IUDs as their sole form of birth control. Participants must live near a research site and be willing to adhere to study guidelines. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the availability of new contraceptive options.

Will I have to stop taking my current medications?

The trial requires that you do not use any non-contraceptive estrogen, progesterone, or testosterone during the study. Additionally, you cannot use corticosteroids while participating in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that VeraCept, a new type of intrauterine device (IUD), is safe to use. In earlier studies, many people found VeraCept, which uses a small amount of copper, comfortable. It presented no major safety issues and worked well for up to 36 months, meaning it did not cause serious side effects for many users.

The ParaGard IUD, compared to VeraCept in this trial, already has FDA approval for pregnancy prevention. It has been used safely and effectively for a long time, indicating it is generally safe for most people.

Both IUDs in this trial appear safe based on past research. However, always consult a healthcare provider to determine if these options are suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

VeraCept is unique because it offers an innovative approach to pregnancy prevention with its flexible design that aims to enhance comfort and reduce side effects compared to traditional IUDs like ParaGard. Unlike ParaGard, which uses copper to prevent pregnancy, VeraCept is designed with a soft, nitinol frame that may improve the insertion experience and user satisfaction. Researchers are excited about VeraCept because it has the potential to provide effective contraception with possibly fewer complications and greater user comfort, making it an appealing option for those seeking long-term birth control.

What evidence suggests that this trial's treatments could be effective for pregnancy prevention?

Research has shown that VeraCept effectively prevents pregnancy, with only 0.2 pregnancies per 100 women over seven years. In this trial, participants will receive either VeraCept or ParaGard. VeraCept uses less than half the copper of traditional IUDs and has proven safe and effective. ParaGard, a well-known copper IUD, also effectively prevents pregnancy. Both IUDs offer reliable birth control but function differently: VeraCept uses a lower amount of copper, while ParaGard uses more. ^{1 2 5 6 7}

Who Is on the Research Team?

David Turok, MD, MPH

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones or prior to recent pregnancy or spontaneous or induced abortion

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

I am over 21 and have had a normal Pap test or a clear HPV test recently.

Exclusion Criteria

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

Study staff or a member of the immediate family of study staff

Any general health, mental health or behavioral condition that, in the opinion of the investigator, could represent an increased risk for the subject or would render the subject less likely to provide the needed study information

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Insertion of VeraCept or ParaGard IUD on Day 1 and monitoring of pharmacokinetic properties

8 weeks

Initial visit for insertion, follow-up visits through Day 56

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants with VeraCept may continue in the study for up to 5 years to assess long-term stability of copper levels

5 years

Visits at Year 3 and Year 5 for PK samples

What Are the Treatments Tested in This Trial?

Interventions

• ParaGard
• VeraCept

Trial Overview 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.

How Is the Trial Designed?

Group I: VeraCept Experimental Treatment 1 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: ParaGard Active Control 1 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.

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+

Synteract, Inc.

Industry Sponsor

Trials

21

Recruited

5,900+

Published Research Related to This Trial

Intrauterine devices (IUDs) are highly effective contraceptives that require only a one-time insertion and can last for 5-10 years, making them a reliable option for preventing unintended pregnancies.

The newer IUDs, such as ParaGard and Mirena, have superior safety profiles compared to older models and demonstrate improved efficacy in preventing both intrauterine and ectopic pregnancies, highlighting their potential as a preferred contraceptive method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in contraception: IUDs from a managed care perspective. Doyle, J., Stern, L., Hagan, M., et al.[2008]

In a 7-year study involving women aged 18 to 38, both the levonorgestrel-releasing IUD and the copper IUD demonstrated very low pregnancy rates (0.2/100 women) and low incidence of side effects, including pelvic infections.

The levonorgestrel IUD significantly reduced menstrual bleeding and related conditions compared to the copper IUD, although it was associated with higher rates of certain side effects like amenorrhea and headaches, particularly in younger women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive devices: a multicenter study. International Committee for Contraception Research (ICCR). Sivin, I., Stern, J.[2022]

Citations

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

Efficacy, Safety, and Tolerability of a New Low-Dose Copper ... A total of 286 women provided 5,640 cycles evaluable for pregnancy. Patients averaged 27.1 years of age. Nulliparous women represented 60.8% of the patients.

2. 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® ...

3. withpower.com withpower.com/trial/phase-3-11-2018-a77ca

VeraCept vs. ParaGard IUDs for Pregnancy Prevention In a 7-year study involving women aged 18 to 38, both the levonorgestrel-releasing IUD and the copper IUD demonstrated very low pregnancy rates (0.2/100 women) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02167763

Comparative Study of the VeraCept Low-Dose Intrauterine ... This is a prospective, randomized, subject-blinded, two arm controlled study of the Safety, Feasibility and Effectiveness of the VeraCept low-dose intrauterine ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/sebela-investigational-iud-further-positive/

Further positive results reported from Sebela's ... According to GlobalData's Medical Device Intelligence Centre, VeraCept is safe and effective in preventing pregnancies using less than half the ...

6. 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 ...

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

Phase 2 efficacy, safety and tolerability results of the ... Conclusions: This novel, low-dose copper contraceptive demonstrated safety and efficacy worthy of expanded study in a phase 3 clinical trial. Article metrics ...