Evaluation of the Efficacy, Safety, and Tolerability of LevoCept

Part of paid clinical trials in Berkeley, California.

Sponsor
Sebela Women's Health Inc.
Study ID
NCT04457076
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Contraception
  • Women at Risk for Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
N/A - 45 Years
Healthy Volunteers
Accepted

Interventions

  • LevoCept — DRUG
    Levonorgestrel-Releasing Intrauterine System

Study Details

To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept

Key Dates

Start date
Jun 1, 2026
Status verified
May 2025
Primary completion
Jun 1, 2030
Completion
Jun 1, 2032

Study Design

Enrollment
1,525 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LevoCept
    LevoCept™ Intrauterine Contraceptive

Primary Outcome Measure

Contraceptive efficacy through 3 years of use as calculated by the Pearl Index [ Time Frame: through 3 years of use ]

Locations (27)

FacilityCityStateZIPSite coordinators
Essential Access Health-BerkeleyBerkeleyCalifornia94710
Amber Van Kessel
[email protected]
213-386-5614
Jade Aganus
[email protected]
213-386-5614
Fung Lam, MD (PRINCIPAL_INVESTIGATOR)
Essential Access Health-Los AngelesLos AngelesCalifornia90010
Seline Guidotti
[email protected]
213-386-5614
Anna Garcia
[email protected]
213-386-5614
Anita Nelson, MD (PRINCIPAL_INVESTIGATOR)
University of California Davis Health System Department of Obstetrics and GynecologySacramentoCalifornia95817
UC Davis ObGyn Research
[email protected]
916-734-6846
Mitchell Creinin, MD (PRINCIPAL_INVESTIGATOR)
Women's Health Care ResearchSan DiegoCalifornia92111
Rovena Reagan, MD
[email protected]
858-505-8672
Rovena Reagan, MD (PRINCIPAL_INVESTIGATOR)
WR-Medical Center for Clinical ResearchSan DiegoCalifornia92108
Merrilee Fleet
[email protected]
919-645-9225
Jessica Backus
[email protected]
858-987-2219
Denis Tarakjian, MD (PRINCIPAL_INVESTIGATOR)
Stanford University, Medical Center, Obstetrics and GynecolocyStanfordCalifornia94305
Tayler Hughes
[email protected]
650-721-1237
Kathryn Bathem
[email protected]
650-724-7826
Paul Blumenthal, MD (PRINCIPAL_INVESTIGATOR)
University Of Colorado Department of Obstetrics & GyncologyAuroraColorado80045-
Emory University School of Medicine Gynecology/ObstetricsAtlantaGeorgia30308
Valerie Jean
[email protected]
404-778-1373
Tiffany Hailstorks, MD (PRINCIPAL_INVESTIGATOR)
Soapstone Center for Clinical ResearchDecaturGeorgia30034
Natalie Hinton
[email protected]
404-534-9359
Sarah Holmes
[email protected]
404-534-9359
Sonya Marks, MD (PRINCIPAL_INVESTIGATOR)
University of HawaiiHonoluluHawaii96826
Emory Bowen
[email protected]
808-203-6574
Jasmine Tyson
[email protected]
808-203-6594
Bliss Kaneshiro, MD (PRINCIPAL_INVESTIGATOR)
IU Health University HospitalIndianapolisIndiana46202
Kathleen Wendholt
[email protected]
317-948-0796
Morgan Runkel
[email protected]
317-948-7587
Jeffrey Peipert, MD, PhD (PRINCIPAL_INVESTIGATOR)
Planned Parenthood North Central StatesMinneapolisMinnesota55408
Bridge McKye
[email protected]
651-389-0675
Marcy Thomas
[email protected]
651-237-4046
Christy Boraas, MD (PRINCIPAL_INVESTIGATOR)
Planned Parenthood of the St. Louis Region and Southwest MissouriManchesterMissouri63088-
Rex Garn Mabey Jr., MDLas VegasNevada89128-
Columbia University Medical CenterNew YorkNew York10032-
University of Cincinnati/Reproductive Medicine ResearchCincinnatiOhio45267-
Ohio State UniversityColumbusOhio43209-
The Ohio State University Ob/Gyn Research OfficeColumbusOhio43210-
Oregon Health & Science UniversityPortlandOregon97239-
Clinical Research of Philadelphia, LLCPhiladelphiaPennsylvania19114-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Magee-Womens Hospital, Center for Family Planning ResearchPittsburghPennsylvania15213-
Advances In HealthHoustonTexas77030-
University of Utah Healthcare Health Sciences CenterSalt Lake CityUtah84132-
Eastern Virginia MedicalNorfolkVirginia23507-
Tidewater Physicians for WomenNorfolkVirginia23502-
Seattle Women's: Health, Research, GynecologySeattleWashington98105-

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