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ContraceptionPhase 2NCT02446821

Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception

A Phase 2 study testing VeraCept in people with Contraception, run by Sebela Women's Health Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
VeraCept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
12 sitesUnited States
Study dates
Jun 2015to 22 Mar 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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);
  • Pre-menopausal, as determined by regular menstrual cycle (28 ± 5 days) for the last 3 months;
  • 2.1 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.
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  • 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).

Who cannot join

  • 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;
  • 5.1 Must have had 2 normal menstrual cycles since the last injection;
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  • 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.
  • 8.1 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:
  • 13.1 Submucosal uterine leiomyoma
  • 13.2 Asherman's syndrome
  • 13.3 Pedunculated polyps
  • 13.4 Bicornuate uterus
  • 13.5 Didelphus or uterine septa
  • 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;
  • Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes), or mucopurulent cervicitis;
  • High risk for STDs (e.g., multiple sexual partners);
  • Known or suspected AIDS;
  • Known intolerance or allergy to nickel or copper, including Wilson's Disease;
  • Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study;
  • Subject had VeraCept placed previously or had 2 attempts at placement;
  • Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Colorado

    Aurora, Colorado

  • Essential Access Health (formerly California Family Health Council)

    Burbank, California

  • University of Cincinnati

    Cincinnati, Ohio

  • Advanced Research Associates

    Corpus Christi, Texas

  • Essential Access Health (formerly California Family Health Council)

    Los Angeles, California

  • Healthcare Clinical Data, Inc

    Miami, Florida

  • Columbia University Medical Center

    New York, New York

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania

  • University of Pennsylvania

    Philadelphia, Pennsylvania

  • Oregon Health and Sciences University

    Portland, Oregon

  • University of California Davis Health System

    Sacramento, California

  • University of Utah

    Salt Lake City, Utah

Other trials in United States

About this study

Official title: Evaluation of the Effectiveness, Safety and Tolerability of the ContraMed VeraCept Intrauterine Copper Contraceptive for Long-Acting Reversible Contraception

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

Read the detailed description

Up to 250 subjects will be consented, screened and have VeraCept placed, with a goal to have 2240 evaluable cycles at 12 months. It is planned that 225 of the 250 subjects will be within the 18-35 year age range, with a total of 2015 evaluable cycles. The remaining 25 subjects will be within the 35-40 year age range.

Follow-up: Physical assessment (office visit) will occur at weeks 6, 13, 26 and 52 after placement, with monthly telephone contact. For those subjects who wish to continue study device use after 12 months, follow-up office visits will occur every 6 months. Additional visits will be conducted if necessary for safety issues.

Follow-up after early study device removal:

Subjects requesting VeraCept removal to become pregnant will be followed to pregnancy or until the subject changes their mind about trying to get pregnant. All subjects in whom VeraCept is removed prior to 12 months, for any reason, will be required to use an alternative contraceptive for the first two weeks following removal. Progestin-only pills will be provided by the sponsor as a contraceptive option during this time unless the subject has a category 4 condition precluding their use.

Study Population: Pre-menopausal women ages 18 - 40, at risk for pregnancy, who are interested in using an 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 by 12 months, failure will be calculated by the Pearl Index.

Safety and Other Outcome

Measures: 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
Conditions
Contraception
Being tested
VeraCept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VeraCeptDrug

    IUD placement of VeraCept

Study groups in NCT02446821
Study groupRoleWhat they receive
VeraCept IUD SystemExperimentalAll women will receive VeraCept.
Receives: Drug: VeraCept

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (3)

  1. VeraCept Placement Success

    The number and percentage of subjects with either a successful or unsuccessful placement will be summarized

    Measured: Visit 1 (Day 1)/ VeraCept Placement

  2. Ease of VeraCept Placement

    Ease of placement of the VeraCept was assessed by the clinician immediately following device placement. The clinician rated the ease of placement using the following options: "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard." This rating was based on the clinician's experience during the placement procedure.

    Measured: Visit 1 (Day 1)/ VeraCept Placement

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

    Bleeding and spotting patterns will be summarized for the first year of treatment (Cycle 1 to Cycle 13) by the mean number of days in each 28-day cycle with bleeding or spotting, bleeding only, and spotting only

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMay 2017
  4. Study completion22 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
VeraCept intrauterine contraceptive device
Masking
None (open label)
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02446821
Sponsor's protocol ID
CMDOC-0008
Status last verified
Feb 2026
First submitted
24 Apr 2015
Last updated
3 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 32168217

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VeraCept in people with Contraception, run by Sebela Women's Health Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446821, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

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