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COMPLETEDPHASE2

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

NCT02882191•Sebela Women's Health Inc.

View on ClinicalTrials.gov

Summary

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

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

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

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
+1 more criteria

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;
+18 more criteria

Locations (16)

Essential Access Health-Berkeley

Berkeley, California, United States

Essential Access Health-Los Angeles

Los Angeles, California, United States

University of California Davis Health System Department of Obstetrics and Gynecology

Sacramento, California, United States

University Of Colorado Department of Obstetrics & Gyncology

Aurora, Colorado, United States

Healthcare Clinical Data, Inc.

North Miami, Florida, United States

Emory University School of Medicine Gynecology/Obstetrics

Atlanta, Georgia, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Columbia University Medical Center

New York, New York, United States

University of Cincinnati Physicians Company, Inc

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

November 1, 2016

Primary Completion Date

July 17, 2018

Completion Date

November 12, 2020

Last Updated

April 12, 2022

Enrollment

279

ACTUAL participants

Conditions

Contraception

Interventions

LevoCept

DRUG

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Contraception

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RECRUITINGNA

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EumenorrheaIntrauterine Devices, Medicated+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Efficacy and Safety of LevoCept

Inclusion Criteria

Exclusion Criteria

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Effect of Different Sex Hormone Profiles for the Response to Physical Training

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