Evaluation of the Efficacy and Safety of LevoCept

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

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: LevoCept

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

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94710
      • Essential Access Health-Berkeley
    • Los Angeles, California, United States, 90010
      • Essential Access Health-Los Angeles
    • Sacramento, California, United States, 95817
      • University of California Davis Health System Department of Obstetrics and Gynecology
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University Of Colorado Department of Obstetrics & Gyncology
  • Florida
    • North Miami, Florida, United States, 33161
      • Healthcare Clinical Data, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine Gynecology/Obstetrics
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Medical Center for Women and Children
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Physicians Company, Inc
    • Columbus, Ohio, United States, 43209
      • Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia, LLC
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Advanced Research Associates
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Healthcare Health Sciences Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Women's: Health, Research, Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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);

2. 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;

3. Sexually active with a male partner who has not had a vasectomy;
4. Reasonably expected to have to coitus at least once monthly during the study period.
5. In a mutually monogamous relationship of at least 3-6 months duration;
6. Seeking to avoid pregnancy for the next 12 months;
7. Willing to use the study device as the sole form of contraception;
8. Willing to accept a risk of pregnancy;
9. Normal PAP or ASC-US with negative high risk HPV test result within the appropriate screen timeframe, and prior to LevoCept insertion;
10. Able and willing to comply with all study tests, procedures, assessment tools and follow-up; and
11. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI).

Exclusion Criteria:

1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle
2. Subject who anticipates separation from her partner for more than 1 cycle within the next 12 months;
3. A previously inserted IUD that has not been removed by the time LevoCept is placed;
4. History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place.;

5. 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;

6. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 12 months of study participation;
7. Postpartum, prior to a minimum of 6 weeks and complete uterine involution;

8. 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

9. Unexplained abnormal uterine bleeding (suspicious for serious condition), before evaluation; Immediately post-septic abortion or puerperal sepsis;
10. Severely heavy or painful menstrual bleeding;
11. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically significant abnormal pap smear requiring evaluation or treatment.
12. Any history of gestational trophoblastic disease with or without detectable elevated ß-hCG levels, or related malignant disease without an intervening normal pregnancy;

13. 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

14. 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;
15. 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;
16. Current or recent (within the last 3 months) untreated acute cervicitis or vaginitis;
17. Known or suspected breast cancer or other progestin-sensitive cancer now or in the past;
18. Known acute liver disease or liver tumor;
19. Subjects who have an established immunodeficiency;
20. High risk for STDs (e.g., multiple sexual partners);
21. Known or suspected HIV infection or clinical AIDS;
22. Known intolerance or allergy to any component of the LevoCept system; including nickel, silicone or tantalum;
23. Subject had LevoCept placed previously or had 2 attempts at placement;
24. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
25. 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.
26. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LevoCept IUD; LevoCept IUD placement	Drug: LevoCept; placement of LevoCept IUD; Other Names: Levonorgestrel-Releasing Intrauterine System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
LevoCept Placement Success	The number and percentage of subjects with either a successful or unsuccessful placement will be summarized	Visit 1 (Day 1)/ LevoCept Placement
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.	Visit 1 (Day 1)/ LevoCept Placement
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	Cycle 1 to Cycle 13 (post IUD placement). Each cycle is 28 days.

Collaborators and Investigators

• Sponsor: Sebela Women's Health Inc.
• Collaborators: Synteract, Inc.
• Investigators: Principal Investigator: David Turok, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): July 17, 2018
• Study Completion (Actual): November 12, 2020

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimated): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: contraception
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: CMDOC-0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No