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Contraceptive
LevoCept for Birth Control
Phase 3
Waitlist Available
Research Sponsored by Sebela Women's Health Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be in compliance with cervical cancer screening guidelines per the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without evidence of disease. Subjects who are age 21 to 24 y/o, at time of informed consent, must have a normal Papanicolaou test (Pap), atypical squamous cells of undetermined significance (ASC-US), or low-grade squamous intraepithelial lesion (LSIL). Subjects who are 25 or older at the time of informed consent must have a normal Pap test or an ASC-US result with a negative high-risk human papilloma virus (HPV) test result within the appropriate screen timeframe per ASCCP guidelines, and prior to the study IUD insertion. Alternatively, the subject must have had a colposcopy performed within the appropriate screen timeframe, and prior to the study IUD insertion that showed no evidence of dysplasia requiring treatment per ASCCP guidelines, or treatment was performed and follow-up at least 6 months after the treatment showed no evidence of disease by clinical evaluation
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years 4 and 5 and cumulatively through years 4 and 5
Awards & highlights
Study Summary
This trial will test the effectiveness of LevoCept in preventing pregnancy.
Who is the study for?
This trial is for pre-menopausal women up to age 45 who are in good health, have regular menstrual cycles, and are sexually active with a male partner. They must not be pregnant or at risk of pregnancy from recent unprotected intercourse, have no history of IUD complications, and agree to use LevoCept as their only birth control method. Women with certain uterine anomalies or severe cervical stenosis, untreated acute cervicitis or vaginitis, liver disease, HIV/AIDS, drug abuse within the last year, high risk for STIs or known allergies to LevoCept components cannot participate.Check my eligibility
What is being tested?
The study is testing the effectiveness of LevoCept as a contraceptive device. It aims to prevent pregnancy in participating women who will use this intrauterine system (IUS) as their sole form of birth control throughout the study period.See study design
What are the potential side effects?
While specific side effects aren't listed here for LevoCept itself; generally speaking IUDs can cause cramping or backaches during insertion; irregular bleeding and spotting between periods initially; heavier periods and worse menstrual cramps may occur but often subside after several months.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I meet the cervical cancer screening requirements and show no evidence of disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ years 4 and 5 and cumulatively through years 4 and 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~years 4 and 5 and cumulatively through years 4 and 5
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 as calculated by the Pearl Index
Secondary outcome measures
Bleeding and spotting patterns
Contraceptive efficacy at Years 4 and 5 as calculated by the Pearl Index
Cumulative LevoCept continuation rates
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LevoCeptExperimental Treatment1 Intervention
LevoCept™ Intrauterine Contraceptive
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LevoCept
2016
Completed Phase 2
~280
Find a Location
Who is running the clinical trial?
Sebela Women's Health Inc.Lead Sponsor
5 Previous Clinical Trials
2,526 Total Patients Enrolled
PRA Health SciencesIndustry Sponsor
94 Previous Clinical Trials
34,766 Total Patients Enrolled
Sebela Pharmaceuticals Inc.Lead Sponsor
5 Previous Clinical Trials
2,526 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a liver disease or tumor.You have a weakened immune system.You have had problems in the past with the intrauterine device (IUD) or intrauterine system (IUS), like it moving out of place, causing a hole, or resulting in pregnancy.You are okay with the possibility of getting pregnant during the trial.I am a woman under 45, have started menstruating, and am in good health.I've used Depo-Provera in the last 10 months and haven't had 2 normal periods since.I plan to use hormone treatments other than birth control during the study.I have had unusual bleeding from my uterus that has not been explained.I might have or am known to have cervical, uterine, or ovarian cancer, or I have an abnormal Pap test needing further evaluation.I have HIV/AIDS.I meet the cervical cancer screening requirements and show no evidence of disease.I have a cervical condition that may prevent treatment application.My male partner is fertile and has not had a vasectomy.You are expected to have sex at least once a month during the study.I am not allergic to levonorgestrel, nickel, titanium, or silicone.I can and will give my consent to participate and share my health information.I experience very heavy or painful periods.I have or had breast cancer or another cancer sensitive to hormones.I have undergone a procedure that has made me sterile.I expect to be away from my partner for more than 6 months while using LevoCept.I have had a pregnancy-related tumor, with or without high ß-hCG levels.I have an untreated infection in my cervix or vagina.You have a history of alcohol or drug abuse within the past year.I am at high risk for STIs due to having multiple sexual partners.You currently experience pain with your intrauterine device (IUD) or intrauterine system (IUS).You have any health or mental health condition that could make it risky for you to participate in the study or make it difficult for you to provide the necessary information.
Research Study Groups:
This trial has the following groups:- Group 1: LevoCept
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.
Are there any dangers that come with taking LevoCept?
"LevoCept is a Phase 3 trial drug, which means that while there is some data affirming its efficacy, multiple rounds of testing have determined it to be safe."
Answered by AI
Can anyone currently enroll in this clinical trial?
"The clinical trial in question, which was last updated on October 24th, 2022, is not currently looking for patients. However, there are 65 other trials that are actively recruiting patients."
Answered by AI
Is this clinical trial exclusive to Canadian hospitals?
"Currently, 30 different clinical trial sites are running this study. For example, Clinical Research of Philadelphia, LLC is participating as well as University of Hawaii in Honolulu and Women's Health Care Research in San Diego."
Answered by AI
Who else is applying?
What site did they apply to?
Essential Access Health-Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
Because I already have 3kids.
PatientReceived no prior treatments
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