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LevoCept for Contraception

This study is testing a new intrauterine device called LevoCept, which releases levonorgestrel (a hormone used in birth control). The goal is to see how well LevoCept prevents pregnancy and if it is safe and tolerable for women. We are looking for women up to 45 years old who are able to get pregnant and want long-term birth control. The main way we'll measure success is by calculating the Pearl Index, which shows how many pregnancies occur per 100 women over three years of using LevoCept. The current status of this study is unclear.

Study design
This is a single-arm, open-label study, meaning all participants will receive LevoCept and everyone will know what treatment they are getting. About 1,525 women will join this study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 3 years, with a possible extension up to 5 years, to assess how well LevoCept prevents pregnancy.

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NCT04457076

Evaluation of the Efficacy, Safety, and Tolerability of LevoCept

Not Yet Recruiting
PHASE3Up to 45InterventionalTreatment
Sebela Women's Health Inc.
~1,525 participants
Updated 2025-05-22 on ClinicalTrials.gov
What's tested:LevoCept

At a glance

Recruiting sites
0 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Contraceptive efficacy through 3 years of use as calculated by the Pearl Index
Measured over through 3 years of use

Conditions

Contraception
Women at Risk for Pregnancy

Explore related trials

Contraception

Where it's being run

27 sites across 16 states
California6
Ohio3
Pennsylvania3
Georgia2
Virginia2
Colorado1
Hawaii1
Indiana1

Who to contact

Amber Van Kessel
[email protected]
213-386-5614 · ext. 2205
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Submucosal uterine leiomyoma
Asherman's syndromes
Pedunculated polyps
Bicornuate uterus
Didelphus or uterine septa 16. Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the investigator, are likely to cause issues during insertion, retention or removal of the IUS; 17. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior trachelectomy or extensive conization that, in the opinion of the investigator would prevent cervical dilation and study drug placement; 18. Untreated or unresolved acute cervicitis or vaginitis; 19. Known or suspected breast cancer or other progestin-sensitive cancer now or in the past; 20. Known acute liver disease or liver tumor; 21. Subjects who have an established immunodeficiency; 22. Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS; 23. At high risk for sexually transmitted infections (e.g. multiple sexual partners); 24. Known intolerance or allergy to any components of LevoCept, including intolerance or allergy to levonorgestrel, nickel, titanium, or silicone; 25. Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study. Subject must have waited at least 30 days from exiting their last study prior to informed consent in this study; 26. Subject has previously been enrolled in a VeraCept or LevoCept study (including the current study); 27. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit; 28. 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; 29. Study staff or a member of the immediate family of study staff.

What this trial measures

  • Contraceptive efficacy through 3 years of use as calculated by the Pearl Indexthrough 3 years of use