NCT02446821

Brief Summary

Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a Phase III Clinical Study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2015

Typical duration for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

August 22, 2025

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

April 24, 2015

Results QC Date

July 1, 2025

Last Update Submit

February 27, 2026

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome Measure is Effectiveness as Calculated 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.

    12 months

Secondary Outcomes (3)

  • VeraCept Placement Success

    Visit 1 (Day 1)/ VeraCept Placement

  • Ease of VeraCept Placement

    Visit 1 (Day 1)/ VeraCept Placement

  • Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)

    Cycle 1 to Cycle 13 (post IUD placement). Each cycle is 28 days.

Study Arms (1)

VeraCept IUD System

EXPERIMENTAL

All women will receive VeraCept.

Drug: VeraCept

Interventions

VeraCeptDRUG

IUD placement of VeraCept

VeraCept IUD System

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18-40 years of age at the time of study initiation;
  • 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);
  • Pre-menopausal, as determined by regular menstrual cycle (28 ± 5 days) for the last 3 months;
  • Based on patient history, when not on hormonal contraceptives;
  • Sexually active with a male partner who has not had a vasectomy;
  • Reasonably expect to have to coitus at least once monthly during the study period.
  • Married or in a steady relationship (e.g., 3-6 months);
  • Seeking to avoid pregnancy for the next 12 months;
  • Willing to use the study device as the sole form of contraception;
  • Willing to accept a risk of pregnancy;
  • Normal PAP or ASC-US with negative high risk HPV test result within the appropriate screen timeframe, unless considered at risk;
  • Able and willing to comply with all study tests, procedures, assessment tools and follow-up; and
  • Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI).

You may not qualify if:

  • Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle
  • Subject who anticipates separation from her partner for more than 1 cycle within the next 12 months;
  • A previously inserted IUD that has not been removed by the time VeraCept is placed;
  • History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place;
  • Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months;
  • Must have had 2 normal menstrual cycles since the last injection;
  • Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 12 months of study participation;
  • Postpartum, prior to a minimum of 6 weeks or complete uterine involution;
  • Exclusively breastfeeding before return of menses; Lactating women will be excluded unless they have had two normal menstrual periods.
  • Must have had 2 normal spontaneous menstrual cycles since delivery
  • Unexplained abnormal uterine bleeding (suspicious for serious condition), before evaluation; Immediately post-septic abortion or puerperal sepsis;
  • Severely heavy or painful menstrual bleeding;
  • Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically significant abnormal pap smear requiring evaluation or treatment
  • Any history of gestational trophoblastic disease with or without detectable elevated ß-hCG levels, or related malignant disease;
  • Known anatomical abnormalities of the uterine cavity that may complicate IUD placement, such as:
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Essential Access Health (formerly California Family Health Council)

Burbank, California, United States

Location

Essential Access Health (formerly California Family Health Council)

Los Angeles, California, United States

Location

University of California Davis Health System

Sacramento, California, United States

Location

University of Colorado

Aurora, Colorado, United States

Location

Healthcare Clinical Data, Inc

Miami, Florida, United States

Location

Columbia University Medical Center

New York, New York, United States

Location

University of Cincinnati

Cincinnati, Ohio, United States

Location

Oregon Health and Sciences University

Portland, Oregon, United States

Location

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Advanced Research Associates

Corpus Christi, Texas, United States

Location

University of Utah

Salt Lake City, Utah, United States

Location

Related Publications (1)

  • Turok DK, Nelson AL, Dart C, Schreiber CA, Peters K, Schreifels MJ, Katz B; VeraCept Phase 2 Clinical Investigator Group. Efficacy, Safety, and Tolerability of a New Low-Dose Copper and Nitinol Intrauterine Device: Phase 2 Data to 36 Months. Obstet Gynecol. 2020 Apr;135(4):840-847. doi: 10.1097/AOG.0000000000003756.

    PMID: 32168217DERIVED

Results Point of Contact

Title
Elizabeth Gray, Manager, Clinical Operations
Organization
Sebela Women's Health Inc.
elizabeth.gray@sebelapharma.com
760-593-8383

Study Officials

  • Anita L Nelson, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: VeraCept intrauterine contraceptive device
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 18, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2017

Study Completion

March 22, 2019

Last Updated

March 3, 2026

Results First Posted

August 22, 2025

Record last verified: 2026-02

Locations

US(12)