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Intrauterine Device
VeraCept IUD for Preventing Pregnancy
Phase 3
Waitlist Available
Led By David Turok, MD, MPH
Research Sponsored by Sebela Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing to use the study drug as the sole form of contraception
Sexually active with a male partner who has not had a vasectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years 4, 5, 6, 7, and 8 and cumulatively through years 4, 5, 6, 7, and 8
Awards & highlights
Study Summary
This trial will assess the contraceptive efficacy of VeraCept, a new contraceptive method.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of using VeraCept may include discomfort during insertion, cramping or pain after placement, irregular menstrual bleeding patterns initially after insertion, possible increased risk of pelvic inflammatory disease (PID), and rare cases of perforation or expulsion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use only the study drug for birth control.
Select...
I am sexually active with a male partner who is not vasectomized.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ years 4, 5, 6, 7, and 8 and cumulatively through years 4, 5, 6, 7, and 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~years 4, 5, 6, 7, and 8 and cumulatively through years 4, 5, 6, 7, and 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
contraceptive efficacy through 3 years of use
Secondary outcome measures
Bleeding and spotting patterns
Contraceptive efficacy at Years 4, 5, 6, 7 and 8
Cumulative VeraCept continuation rates
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: VeraCeptExperimental Treatment1 Intervention
VeraCept™ Intrauterine Contraceptive
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
2,431 Total Patients Enrolled
2 Trials studying Women at Risk for Pregnancy
1,566 Patients Enrolled for Women at Risk for Pregnancy
Synteract, Inc.Industry Sponsor
20 Previous Clinical Trials
4,282 Total Patients Enrolled
1 Trials studying Women at Risk for Pregnancy
41 Patients Enrolled for Women at Risk for Pregnancy
Sebela Women's Health Inc.Lead Sponsor
5 Previous Clinical Trials
2,431 Total Patients Enrolled
2 Trials studying Women at Risk for Pregnancy
1,566 Patients Enrolled for Women at Risk for Pregnancy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use only the study drug for birth control.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.I am sexually active with a male partner who is not vasectomized.You are sexually active and expect to have sex at least once a month during the study.I have had unusual bleeding that cannot be explained.I may have cervical, uterine, or ovarian cancer, or I have an abnormal Pap smear needing further evaluation.I have had surgery or have a condition that makes it hard to treat my cervix.I am a woman under 45, have started menstruating, and am not yet in menopause.I plan to use hormone treatments other than contraceptives during the study.I am over 21 and have had a normal Pap test or a clear HPV test recently.I am not breastfeeding, or I have had 2 normal periods since stopping.I experience very heavy or painful periods.I have had a pregnancy-related tumor, with or without high ß-hCG levels.I can and will sign a consent form and allow my health information to be shared.I am sexually active with a man who is not sterilized.You are okay with the possibility of becoming pregnant during the trial.I have HIV/AIDS.I have not had untreated cervicitis or vaginitis in the last 3 months.You have regular menstrual cycles defined as occurring every 21-35 days when not using hormones or prior to recent pregnancy or spontaneous or induced abortion.
Research Study Groups:
This trial has the following groups:- Group 1: VeraCept
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is this research project being administrated in numerous hospitals within the city limits?
"Patients can be enrolled in this trial at The Jackson Clinic in Jackson, Tennessee, Magee-Womens Hospital in Pittsburgh, Pennsylvania, Seattle Women's Health in Seattle, Washington, and 41 other locations."
Answered by AI
Is VeraCept effective in curbing the risk of patient harm?
"There is pre-existing clinical data affirming VeraCept's efficacy, and thus it received a safety score of 3."
Answered by AI
Can new patients join this research project?
"This particular trial, as indicated on clinicaltrials.gov, is not currently enrolling patients. The trial was initially posted on 8/22/2018, with the most recent update taking place on 10/24/2022. Although this study is not looking for participants, there are 3 other trials that are."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Nevada
How old are they?
18 - 65
What site did they apply to?
MomDoc Women's Health Research
Planned Parenthood of the St. Louis Region and Southwest Missouri
Rex Garn Mabey Jr., MD
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I’ve tried two other IUDs and the pill and it seems to be messing with my hormones, so I’d like to see if VeraCept helps restabilize my hormones.
PatientReceived 2+ prior treatments
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