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Evaluation of the Efficacy and Safety of LevoCept

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ClinicalTrials.gov Identifier: NCT02882191
Recruitment Status : Active, not recruiting
First Posted : August 29, 2016
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
Sebela Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Contraception Drug: LevoCept Phase 2

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  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness, Safety and Tolerability of LevoCept (Levonorgestrel-Releasing Intrauterine System) for Long-Acting Reversible Contraception
Study Start Date : November 2016
Actual Primary Completion Date : July 17, 2018
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: LevoCept IUD
LevoCept IUD placement
Drug: LevoCept
placement of LevoCept IUD
Other Name: Levonorgestrel-Releasing Intrauterine System




Primary Outcome Measures :
  1. absence of pregnancy during LevoCept use [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882191


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

Responsible Party: Sebela Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02882191     History of Changes
Other Study ID Numbers: CMDOC-0022
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sebela Pharmaceuticals Inc.:
contraception

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral