๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-05-19

Evaluation of the Efficacy, Safety, and Tolerability of LevoCept (NCT04457076)

A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate LevoCeptโ„ข, a Long-Acting Reversible Intrauterine System for Contraceptive Efficacy, Safety, and Tolerability

๐ŸŸก Not Yet Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Sebela Women's Health Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Essential Access Health-Berkeley โ€” Berkeley, California

Age range: Not specified to 45 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (27 Sites)

Showing the first 25 of 27 sites.

  • Essential Access Health-Berkeley โ€” Berkeley, California
  • Essential Access Health-Los Angeles โ€” Los Angeles, California
  • University of California Davis Health System Department of Obstetrics and Gynecology โ€” Sacramento, California
  • WR-Medical Center for Clinical Research โ€” San Diego, California
  • Women's Health Care Research โ€” San Diego, California
  • Stanford University, Medical Center, Obstetrics and Gynecolocy โ€” Stanford, California
  • University Of Colorado Department of Obstetrics & Gyncology โ€” Aurora, Colorado
  • Emory University School of Medicine Gynecology/Obstetrics โ€” Atlanta, Georgia
  • Soapstone Center for Clinical Research โ€” Decatur, Georgia
  • University of Hawaii โ€” Honolulu, Hawaii
  • IU Health University Hospital โ€” Indianapolis, Indiana
  • Planned Parenthood North Central States โ€” Minneapolis, Minnesota
  • Planned Parenthood of the St. Louis Region and Southwest Missouri โ€” Manchester, Missouri
  • Rex Garn Mabey Jr., MD โ€” Las Vegas, Nevada
  • Columbia University Medical Center โ€” New York, New York
  • University of Cincinnati/Reproductive Medicine Research โ€” Cincinnati, Ohio
  • Ohio State University โ€” Columbus, Ohio
  • The Ohio State University Ob/Gyn Research Office โ€” Columbus, Ohio
  • Oregon Health & Science University โ€” Portland, Oregon
  • Hospital of the University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • Clinical Research of Philadelphia, LLC โ€” Philadelphia, Pennsylvania
  • Magee-Womens Hospital, Center for Family Planning Research โ€” Pittsburgh, Pennsylvania
  • Advances In Health โ€” Houston, Texas
  • University of Utah Healthcare Health Sciences Center โ€” Salt Lake City, Utah
  • Tidewater Physicians for Women โ€” Norfolk, Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (213) 386-5614

Email: avankessel@essentialaccess.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—