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

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ClinicalTrials.gov Identifier: NCT02446821
Recruitment Status : Active, not recruiting
First Posted : May 18, 2015
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
Health Decisions
Information provided by (Responsible Party):
ContraMed LLC

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

Condition or disease Intervention/treatment Phase
Contraception Device: VeraCept Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Intervention Model: Single Group Assignment
Intervention Model Description: VeraCept intrauterine contraceptive device
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness, Safety and Tolerability of the ContraMed VeraCept Intrauterine Copper Contraceptive for Long-Acting Reversible Contraception
Study Start Date : June 2015
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: VeraCept IUD System
All women will receive VeraCept.
Device: VeraCept
IUD placement of VeraCept




Primary Outcome Measures :
  1. The primary outcome measure is effectiveness, evaluated as the absence of pregnancy by 12 months, failure will be calculated by the Pearl Index [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Study Device Placement (Placement success and ease of placement) [ Time Frame: 12 months ]
    Placement success and ease of placement

  2. Safety (adverse and serious adverse events) [ Time Frame: 12 months ]
    AEs and SAEs

  3. Tolerability (bleeding and spotting patterns and discontinuation rate) [ Time Frame: 12 months ]
    bleeding and spotting patterns and discontinuation rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ± 5 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 expect to have to coitus at least once monthly during the study period.
  5. Married or in a steady relationship (e.g., 3-6 months);
  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, unless considered at risk;
  10. Able and willing to comply with all study tests, procedures, assessment tools and follow-up; and
  11. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI).

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 VeraCept is placed;History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place;
  4. History of previous serious IUD complications;
  5. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months; 6.1 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 or 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.

    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;
  10. Severely heavy or painful menstrual bleeding;
  11. 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;
  12. Known anatomical abnormalities of the uterine cavity that may complicate IUD placement, such as:

    12.1 Submucosal uterine leiomyoma 12.2 Asherman's syndrome 12.3 Pedunculated polyps 12.4 Bicornuate uterus 12.5 Didelphus or uterine septa

  13. 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;
  14. Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes), or mucopurulent cervicitis;
  15. High risk for STDs (e.g., multiple sexual partners);
  16. Known or suspected AIDS;
  17. Known intolerance or allergy to nickel or copper, including Wilson's Disease;
  18. Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study;
  19. Subject had VeraCept placed previously or had 2 attempts at placement;
  20. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
  21. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446821


Locations
United States, California
California Family Health Council
Los Angeles, California, United States
University of California Davis Health System
Sacramento, California, United States
United States, Colorado
University of Colorado
Aurora, Colorado, United States
United States, Florida
Healthcare Clinical Data, Inc
Miami, Florida, United States
United States, New York
Columbia University Medical Center
New York, New York, United States
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States
United States, Pennsylvania
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Advanced Research Associates
Corpus Christi, Texas, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
ContraMed LLC
Health Decisions
Investigators
Principal Investigator: Anita L Nelson, MD University of California, Los Angeles

Responsible Party: ContraMed LLC
ClinicalTrials.gov Identifier: NCT02446821     History of Changes
Other Study ID Numbers: CMDOC-0008
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Contraceptive Agents
Copper
Reproductive Control Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances