Evaluation of the Efficacy and Safety of LevoCept

NCT02882191 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CMDOC-0022
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Contraception

Keywords

contraception

Outcome Measures

Primary Outcomes (2)

• 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.

  1 Year, 2 Years, and 3 Years

• 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

  Years 1-3

Secondary Outcomes (3)

• LevoCept Placement Success

  Visit 1 (Day 1)/ LevoCept Placement

• Ease of LevoCept Placement

  Visit 1 (Day 1)/ LevoCept Placement

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

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

Study Arms (1)

LevoCept IUD

EXPERIMENTAL

LevoCept IUD placement

Drug: LevoCept

Interventions

LevoCept DRUG

placement of LevoCept IUD

Also known as: Levonorgestrel-Releasing Intrauterine System

LevoCept IUD

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18-40 years of age at the time of study initiation;
• 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;
• 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.
• 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).

You may not qualify if:

• 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;
• Must have had 2 normal menstrual cycles since the last injection;
• 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.
• 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:

Sponsors & Collaborators

• Sebela Women's Health Inc.: lead
• Synteract, Inc.: collaborator

Study Sites (16)

Essential Access Health-Berkeley

Berkeley, California, 94710, United States

Location

Essential Access Health-Los Angeles

Los Angeles, California, 90010, United States

Location

University of California Davis Health System Department of Obstetrics and Gynecology

Sacramento, California, 95817, United States

Location

University Of Colorado Department of Obstetrics & Gyncology

Aurora, Colorado, 80045, United States

Location

Healthcare Clinical Data, Inc.

North Miami, Florida, 33161, United States

Location

Emory University School of Medicine Gynecology/Obstetrics

Atlanta, Georgia, 30322, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Cincinnati Physicians Company, Inc

Cincinnati, Ohio, 45267, United States

Location

Ohio State University

Columbus, Ohio, 43209, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

University of Utah Healthcare Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Seattle Women's: Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

Results Point of Contact

• Title: Elizabeth Gray, Manager, Clinical Operations
• Organization: Sebela Women's Health

elizabeth.gray@sebelapharma.com

760-593-8383

Study Officials

• David Turok, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: November 1, 2016
• Primary Completion: July 17, 2018
• Study Completion: November 12, 2020
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)