VeraCept vs. ParaGard IUDs for Pregnancy Prevention

(IUD Trial)

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

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment ParaGard and VeraCept IUDs for pregnancy prevention?

Research shows that intrauterine devices (IUDs), like ParaGard and VeraCept, are highly effective for preventing pregnancy, with a global cumulative pregnancy rate that is very low. Copper IUDs, such as ParaGard, work by releasing copper, which acts as a spermicide (kills sperm), and are recognized as safe and effective contraceptive options. ^{1 2 3 4 5}

Is it safe to use VeraCept and ParaGard IUDs for pregnancy prevention?

Both VeraCept and ParaGard IUDs are generally considered safe for use in humans. They do not increase the risk of infertility or pelvic infections in long-term users, and they are effective contraceptive options. However, there are some risks, such as increased blood loss, uterine perforation, and a higher chance of ectopic pregnancy if pregnancy occurs with an IUD in place. ^{1 3 5 6 7}

How does the VeraCept IUD differ from other IUDs for pregnancy prevention?

VeraCept is unique because it uses a nitinol frame and has a lower copper surface area (175 square-mm) compared to the traditional copper T380S IUD, which may offer different benefits in terms of comfort and side effects. ^{1 2 3 4 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

A randomized comparison of a novel nitinol-frame low-dose-copper intrauterine contraceptive and a copper T380S intrauterine contraceptive. [2018]

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

Contraceptive efficacy of intrauterine devices. [2008]

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

Reappearance of the intrauterine device: a 'user-friendly' contraceptive. [2005]

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

Experience with two different medicated intrauterine devices: a comparative study of the Progestasert and Nova-T. [2019]

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

Intrauterine devices: medicated and nonmedicated. [2019]

6. United States 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). [2022]

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

Use of the Mirena LNG-IUS and Paragard CuT380A intrauterine devices in nulliparous women. [2022]

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

Advances in contraception: IUDs from a managed care perspective. [2008]