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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
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
IUD Trial Summary
This trial will compare the pharmacokinetic properties of the new intrauterine contraceptive VeraCept to the current standard, ParaGard.
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.Check my eligibility
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.See study design
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.
IUD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am sexually active with a man who is not sterilized.
Select...
I am a woman under 45, have started menstruating, and am in good health.
Select...
I agree to use only the study drug for birth control.
IUD Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Observed systemic copper bioavailability of VeraCept vs. ParaGard
Secondary outcome measures
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
IUD 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
Find a Location
Who is running the clinical trial?
Sebela Pharmaceuticals Inc.Lead Sponsor
5 Previous Clinical Trials
4,010 Total Patients Enrolled
2 Trials studying Women at Risk for Pregnancy
3,145 Patients Enrolled for Women at Risk for Pregnancy
Sebela Women's Health Inc.Lead Sponsor
5 Previous Clinical Trials
4,010 Total Patients Enrolled
2 Trials studying Women at Risk for Pregnancy
3,145 Patients Enrolled for Women at Risk for Pregnancy
Synteract, Inc.Industry Sponsor
20 Previous Clinical Trials
5,861 Total Patients Enrolled
1 Trials studying Women at Risk for Pregnancy
1,620 Patients Enrolled for Women at Risk for Pregnancy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to use hormone treatments other than contraceptives during the study.I am currently taking corticosteroids.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.I have had a pregnancy-related tumor, with or without high ß-hCG levels.I may have cervical, uterine, or ovarian cancer, or I have an abnormal Pap smear needing further evaluation.I have not had untreated cervicitis or vaginitis in the last 3 months.I have HIV/AIDS.I have a uterine condition that could affect medication placement.I am a woman under 45, have started menstruating, and am in good health.I experience very heavy or painful periods.I can and will sign a consent form and allow my health information to be shared.I have had unusual bleeding from my uterus that cannot be explained.I agree to use only the study drug for birth control.You are able and willing to comply with all study tests, procedures, assessment tools and follow-up.I am sexually active with a man who is not vasectomized.You are sexually active and expect to have sex at least once a month during the study.You are willing to become pregnant and understand the risks involved.
Research Study Groups:
This trial has the following groups:- Group 1: VeraCept
- Group 2: ParaGard
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary medical conditions that VeraCept has been shown to improve?
"VeraCept can be used to treat a trace element deficiency, weigh >40 kg, and receive iud therapy."
Answered by AI
Did VeraCept receive the green light from the FDA?
"There is existing clinical data that supports VeraCept's efficacy, which is why it was given a safety score of 3."
Answered by AI
Is VeraCept a common medication for clinical trials?
"The first recorded study of VeraCept took place in 2015 at City of Hope Medical Center. As of now, there have been a total 20 completed studies with 7 more currently active. The majority of these current trials are based out the Seattle, Washington area."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Seattle Women's Health
Why did patients apply to this trial?
I am interested in a copper IUD option that is smaller than the ParaGuard.
PatientReceived no prior treatments
I've tried a couple of other IUDs and have been looking to find a non-hormonal IUD.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How often will I need to travel out for visits?
PatientReceived no prior treatments
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