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ContraceptionPhase 2NCT02882191

Evaluation of the Efficacy and Safety of LevoCept

A Phase 2 study testing LevoCept in people with Contraception, run by Sebela Women's Health Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
LevoCept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
279 participants
Where
16 sitesUnited States
Study dates
Nov 2016to 12 Nov 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between 18-40 years of age at the time of study initiation;
  • 1.1 Enrollment will be targeted for 225 subjects aged 18-35 (for safety and effectiveness analyses) and an additional 25 subjects aged 36-40 (for safety only) (note: all subjects will be included in the analysis for device placement and tolerability);
  • Pre-menopausal, as determined by regular menstrual cycle (28 ± 7 days) for the last 3 months;
  • 2.1 Based on patient history, when not on hormonal contraceptives;
  • Sexually active with a male partner who has not had a vasectomy;
  • Reasonably expected to have to coitus at least once monthly during the study period.
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  • In a mutually monogamous relationship of at least 3-6 months duration;
  • Seeking to avoid pregnancy for the next 12 months;
  • Willing to use the study device as the sole form of contraception;
  • Willing to accept a risk of pregnancy;
  • Normal PAP or ASC-US with negative high risk HPV test result within the appropriate screen timeframe, and prior to LevoCept insertion;
  • Able and willing to comply with all study tests, procedures, assessment tools and follow-up; and
  • Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI).

Who cannot join

  • Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle
  • Subject who anticipates separation from her partner for more than 1 cycle within the next 12 months;
  • A previously inserted IUD that has not been removed by the time LevoCept is placed;
  • History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place.;
  • Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months;
  • 5.1 Must have had 2 normal menstrual cycles since the last injection;
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  • Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 12 months of study participation;
  • Postpartum, prior to a minimum of 6 weeks and complete uterine involution;
  • Exclusively breastfeeding before return of menses; Lactating women will be excluded unless they have had two normal menstrual periods prior to enrollment.
  • 8.1 Must have had 2 normal spontaneous menstrual cycles since delivery
  • Unexplained abnormal uterine bleeding (suspicious for serious condition), before evaluation; Immediately post-septic abortion or puerperal sepsis;
  • Severely heavy or painful menstrual bleeding;
  • Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically significant abnormal pap smear requiring evaluation or treatment.
  • Any history of gestational trophoblastic disease with or without detectable elevated ß-hCG levels, or related malignant disease without an intervening normal pregnancy;
  • Any congenital or acquired uterine anomaly that may complicate IUD placement, such as:
  • 13.1 Submucosal uterine leiomyoma
  • 13.2 Asherman's syndrome
  • 13.3 Pedunculated polyps
  • 13.4 Bicornuate uterus
  • 13.5 Didelphus or uterine septa
  • Any distortions of the uterine cavity (e.g. fibroids), in the opinion of the investigator, likely to cause issues during insertion, retention or removal of the IUD;
  • 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 device placement;
  • Current or recent (within the last 3 months) untreated acute cervicitis or vaginitis;
  • Known or suspected breast cancer or other progestin-sensitive cancer now or in the past;
  • Known acute liver disease or liver tumor;
  • Subjects who have an established immunodeficiency;
  • High risk for STDs (e.g., multiple sexual partners);
  • Known or suspected HIV infection or clinical AIDS;
  • Known intolerance or allergy to any component of the LevoCept system; including nickel, silicone or tantalum;
  • Subject had LevoCept placed previously or had 2 attempts at placement;
  • Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
  • Any general 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.
  • Subject is currently participating or has participated in another clinical study involving another investigational agent within 30 days of the planned LevoCept insertion date or is planning participation in another clinical trial with an investigational agent within 52 weeks (visit 6) after insertion.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Emory University School of Medicine Gynecology/Obstetrics

    Atlanta, Georgia, 30322

  • University Of Colorado Department of Obstetrics & Gyncology

    Aurora, Colorado, 80045

  • Essential Access Health-Berkeley

    Berkeley, California, 94710

  • University of Cincinnati Physicians Company, Inc

    Cincinnati, Ohio, 45267

  • Ohio State University

    Columbus, Ohio, 43209

  • Advanced Research Associates

    Corpus Christi, Texas, 78414

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Essential Access Health-Los Angeles

    Los Angeles, California, 90010

  • Columbia University Medical Center

    New York, New York, 10032

  • Healthcare Clinical Data, Inc.

    North Miami, Florida, 33161

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of California Davis Health System Department of Obstetrics and Gynecology

    Sacramento, California, 95817

  • University of Utah Healthcare Health Sciences Center

    Salt Lake City, Utah, 84132

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Evaluation of the Effectiveness, Safety and Tolerability of LevoCept (Levonorgestrel-Releasing Intrauterine System) for Long-Acting Reversible Contraception

To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study

Read the detailed description

Study Design:

Prospective, multi-center, single-arm, open-label, Phase II clinical study

Approximately 250 subjects will be enrolled at about 14 centers in the US.

Study Population: Pre-menopausal women ages 18 - 40, at risk for pregnancy, who are interested in using only this intrauterine contraceptive for birth control will be eligible for this study. Subjects must provide written informed consent and meet the study subject selection criteria without any exclusions as outlined in the Clinical Investigation Plan (CIP).

Primary Effectiveness Outcome:

The primary outcome measure is effectiveness, evaluated as the absence of pregnancy during LevoCept use.

Safety and other outcome measures include:

Study Device Placement:

  • Ease of placement
  • Placement success

Safety:

  • Serious Adverse Events
  • Adverse Events

Tolerability:

  • Bleeding and spotting patterns
  • Discontinuation rate and reasons for discontinuation
Conditions
Contraception
Being tested
LevoCept
Keywords
contraception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevoCeptDrug

    Also called Levonorgestrel-Releasing Intrauterine System

    placement of LevoCept IUD

Study groups in NCT02882191
Study groupRoleWhat they receive
LevoCept IUDExperimentalLevoCept IUD placement
Receives: Drug: LevoCept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Contraceptive Efficacy Through During LevoCept Use

    Contraceptive efficacy through 3 years of use, as assessed by the Pearl Index. The Pearl Index is calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. On-treatment pregnancy is defined as the estimated conception date being on or after the insertion date (must be a successful insertion) and no more than 7 days after the study drug is removed or expelled. One women year is defined as comprising thirteen 28-day cycles. A lower Pearl Index indicates greater contraceptive effectiveness.

    Measured: 1 Year, 2 Years, and 3 Years

  2. Cumulative Pregnancy Percentage

    A life table analysis (using Kaplan-Meier) of pregnancies will be performed for the EP population to present the cumulative pregnancy percentage

    Measured: Years 1-3

Secondary outcomes (3)

  1. LevoCept Placement Success

    The number and percentage of subjects with either a successful or unsuccessful placement will be summarized

    Measured: Visit 1 (Day 1)/ LevoCept Placement

  2. Ease of LevoCept Placement

    Ease of placement of the LevoCept was assessed by the clinician immediately following device placement. The clinician rated the ease of placement using the following options: "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard." This rating was based on the clinician's experience during the placement procedure.

    Measured: Visit 1 (Day 1)/ LevoCept Placement

  3. Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)

    Bleeding and spotting patterns will be summarized for the first year of treatment (Cycle 1 to Cycle 13) by the mean number of days in each 28-day cycle with bleeding or spotting and spotting only

    Measured: Cycle 1 to Cycle 13 (post IUD placement). Each cycle is 28 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion17 Jul 2018
  4. Study completion12 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02882191
Sponsor's protocol ID
CMDOC-0022
Status last verified
Apr 2026
First submitted
24 Aug 2016
Last updated
23 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LevoCept in people with Contraception, run by Sebela Women's Health Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contraceptive Efficacy Through During LevoCept Use (time frame: 1 Year, 2 Years, and 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02882191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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