VeraCept IUD for Preventing Pregnancy

Recruiting at 40 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

1620 Participants Needed

Trial Summary

What is the purpose of this trial?

To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept

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.

How does the VeraCept IUD differ from other treatments for preventing pregnancy?

The VeraCept IUD is unique because it is a frameless intrauterine device, which means it does not have the conventional T-shape and cross-arms, making it suitable for women with smaller or narrower uteruses. This design reduces the risk of expulsion and displacement, offering a more comfortable and compatible option for long-term contraception. ^{1 2 3 4 5}

Research Team

David Turok, MD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Synteract, Inc.

Industry Sponsor

Trials

21

Recruited

5,900+

References

1. Austria pubmed.ncbi.nlm.nih.gov

Intrauterine steroid contraceptives. [2013]

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

Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. [2019]

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

Intrauterine devices: an update. [2022]

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

Practical Advice for Emergency IUD Contraception in Young Women. [2020]

5. Turkey pubmed.ncbi.nlm.nih.gov

Intra-cesarean insertion and fixation of frameless intrauterine devices. [2020]