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Evaluation of Efficacy, Safety and Tolerability of VeraCept IUD

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ClinicalTrials.gov Identifier: NCT03633799
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
Sebela Pharmaceuticals Inc.

Brief Summary:
To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept

Condition or disease Intervention/treatment Phase
Women at Risk for Pregnancy Drug: VeraCept Phase 3

Detailed Description:

Study Design:

Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 5 years

Number of Subjects:

Approximately 1,605 subjects will be enrolled into the study

Study Population:

Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and who desire a long-term intrauterine contraceptive for birth control will be eligible for this study.

Primary Endpoint:

The primary endpoint is the contraceptive efficacy through 3 years of use, as assessed by the Pearl Index.

Secondary endpoints:

Contraceptive Efficacy:

  • Pearl Index at Years 4 and 5, as well as cumulatively through Years 4 and 5.
  • Pregnancy percentage by life table analysis (Kaplan-Meier) at Years 1, 2, 3, 4 and 5

Study drug placement:

  • Ease of VeraCept placement
  • Placement success

Safety:

  • Serious adverse events (SAEs)
  • Adverse events (AEs)
  • Pelvic infection (pelvic inflammatory disease (PID) or endometritis)
  • Ectopic pregnancies
  • Uterine perforations
  • Dysmenorrhea
  • Abdominal pain
  • Expulsion rates at Years 1, 2, 3, 4 and 5

Tolerability:

  • Bleeding and spotting patterns
  • Insertion pain assessed immediately after insertion
  • Continuation rates at Years 1, 2, 3, 4 and 5
  • Reasons for discontinuation Return to fertility
  • Pregnancy rate in subjects who request VeraCept removal specifically to become pregnant. Subjects who desire pregnancy after having VeraCept removed will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1605 participants
Intervention Model: Single Group Assignment
Intervention Model Description: VeraCept Intrauterine Device (IUD)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate VeraCept™, a Long-Acting Reversible Intrauterine Contraceptive for Contraceptive Efficacy, Safety, and Tolerability
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : October 2024

Arm Intervention/treatment
Experimental: VeraCept
VeraCept™ Intrauterine Contraceptive
Drug: VeraCept
VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method




Primary Outcome Measures :
  1. contraceptive efficacy through 3 years of use [ Time Frame: through 3 years of use ]
    contraceptive efficacy through 3 years of use, as assessed by the Pearl Index


Secondary Outcome Measures :
  1. Contraceptive efficacy at Years 4 and 5 [ Time Frame: Years 4 and 5 and cumulatively through Years 4 and 5 ]
    Pearl Index will be calculated for Years 4 and 5, as well as cumulatively through Years 4 and 5

  2. cumulative pregnancy percentage [ Time Frame: Years 1 through 5 ]
    A life table analysis (using Kaplan-Meier) of pregnancies will be performed for the EP population to present the cumulative pregnancy percentage for Years 1 through 5

  3. Ease of VeraCept placement [ Time Frame: Visit 1 (Day 1) / VeraCept placement ]
    Ease of VeraCept placement will be summarized for the Safety population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard).

  4. VeraCept Placement success [ Time Frame: Visit 1 (Day 1) / VeraCept placement ]
    The number and percentage of subjects with either a successful or unsuccessful placement will be summarized for the ITT and Safety populations.

  5. Incidence of AEs and SAEs [ Time Frame: 5 years ]
    Incidence of AEs and SAEs will be summarized for the ITT population, as well as for the Safety population for all subjects and the 36 to 45-year-old safety sub-population.

  6. Bleeding and spotting patterns [ Time Frame: Through year 1 ]
    Bleeding and spotting patterns will be summarized for the ECYC population for the first year of treatment by the number of days in each 28-day cycle with bleeding or spotting, bleeding only and spotting only

  7. Insertion pain assessed immediately after insertion [ Time Frame: Visit 1 (Day 1), immediately after insertion ]
    Summarized for subjects with and without prior prophylactic pain medication as measured by an 11-Point Numeric Pain Rating Scale. The scale being 0 - 10 with 0 being no pain and 10 being the worse pain

  8. Cumulative VeraCept continuation rates [ Time Frame: Years 1 through 5 ]

    Cumulative VeraCept continuation rates for Years 1 through 5 will be summarized using Kaplan-Meier methods for the Safety population. The number and percentage of subjects with each reason for discontinuation will be summarized.

    Continuation rates at Years 1, 2, 3, 4 and 5, Reasons for discontinuation will be summarized.


  9. Cumulative VeraCept expulsion rates [ Time Frame: Years 1 through 5 ]
    Cumulative VeraCept expulsion rates for Years 1 through 5 will be summarized using Kaplan-Meier methods for the Safety population.

  10. Return to Fertility. Only for subjects requesting VeraCept removal to become pregnant. [ Time Frame: Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first. ]
    The number and percentage of subjects with each return to fertility response will be summarized for the Safety population.



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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women who are at risk for pregnancy will be eligible for this study
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed consent/assent and in good general health;
  2. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones or prior to recent pregnancy or spontaneous or induced abortion;
  3. Sexually active with a male partner who has not had a vasectomy;
  4. Reasonably expect to have coitus at least once monthly during the study period;
  5. In a mutually monogamous relationship of at least 3 months duration;
  6. Seeking to avoid pregnancy for the duration of the study;
  7. Willing to use the study drug as the sole form of contraception;
  8. Willing to accept a risk of pregnancy;
  9. Subjects who are age 21 or older, at time of informed consent, must have a normal papanicolaou test (Pap) or atypical squamous cells of undetermined significance (ASC-US) with negative high risk human papilloma virus (HPV) test result within the appropriate screen timeframe per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines, and prior to the study IUD insertion. Alternatively, the subject must have had a colposcopy performed within the appropriate screen timeframe, and prior to the study IUD insertion that showed no evidence of dysplasia requiring treatment per ASCCP guidelines, or treatment was performed and follow-up at least 6 months after the treatment showed no evidence of disease by clinical evaluation;
  10. Able and willing to comply with all study tests, procedures, assessment tools (including e-diary) and follow-up;
  11. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI). Unemancipated subjects under 18 years old must provide assent and have written parental consent documented on the consent form consistent with local legal requirements;
  12. Plan to reside within a reasonable driving distance of a research site for the duration of the study.
  13. Subject agrees not to self-remove VeraCept

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 a 6-month period during use of VeraCept;
  3. A previously inserted intrauterine device (IUD) that has not been removed by the time the study IUD is placed;
  4. History of previous IUD complications, such as perforation, expulsion, or pregnancy with IUD in place;
  5. Pain with current IUD;
  6. Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months (if injection greater than 3 months ago, must have had 2 normal menstrual cycles since the last injection);
  7. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 60 months of study participation;
  8. Exclusively breastfeeding before return of menses; lactating women will be excluded unless they have had 2 normal menstrual periods prior to enrollment;
  9. Unexplained abnormal uterine bleeding (suspicious for a serious condition), including bleeding 4 weeks 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;
  12. Any history of gestational trophoblastic disease with or without detectable elevated ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;
  13. Any congenital or acquired uterine anomaly that may complicate study drug placement, such as:

    • Submucosal uterine leiomyoma
    • Asherman's syndromes
    • Pedunculated polyps
    • Bicornuate uterus
    • Didelphus or uterine septa
  14. Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the investigator, are likely to cause issues during insertion, retention or removal of the IUD;
  15. 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 drug placement;
  16. Untreated acute cervicitis or vaginitis within the past 3 months;
  17. Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;
  18. Subjects who have an established immunodeficiency;
  19. Known intolerance or allergy to any components of VeraCept including intolerance or allergy to nickel, titanium, or copper, and including Wilson's Disease;
  20. Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study. Subject must have waited at least 30 days from exiting their last study prior to informed consent in this study;
  21. Subject has been enrolled in a previous VeraCept study;
  22. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
  23. Any general health, mental 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;
  24. Study staff or a member of the immediate family of study staff.

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): NCT03633799


Contacts
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Contact: Monique Gagnon 760-268-8213 monique.gagnon@synteract.com

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Sponsors and Collaborators
Sebela Pharmaceuticals Inc.
Synteract, Inc.

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Responsible Party: Sebela Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03633799     History of Changes
Other Study ID Numbers: CMDOC-0042
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs