LevoCept for Birth Control
Recruiting at 29 trial locations
Age: < 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Sebela Women's Health Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
Research Team
Eligibility Criteria
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.Inclusion Criteria
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.
Seeking to avoid pregnancy for the duration of the study
See 10 more
Exclusion Criteria
A previously inserted IUD/IUS that has not been removed by the time the study IUS is placed
I have a liver disease or tumor.
You have a weakened immune system.
See 25 more
Treatment Details
Interventions
- LevoCept (Contraceptive)
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: LevoCeptExperimental Treatment1 Intervention
LevoCept™ Intrauterine Contraceptive
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sebela Women's Health Inc.
Lead Sponsor
Trials
6
Recruited
4,100+
Sebela Pharmaceuticals Inc.
Lead Sponsor
Trials
6
Recruited
4,100+
PRA Health Sciences
Industry Sponsor
Trials
95
Recruited
42,500+
Colin Shannon
PRA Health Sciences
Chief Executive Officer since 2010
BSc in Economics and MBA from the Wharton School, University of Pennsylvania
Dr. Kirsten Gruis
PRA Health Sciences
Chief Medical Officer since 2023
MD from McGill University