Evaluation of Efficacy, Safety and Tolerability of VeraCept IUD


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Trial ID: NCT03633799


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

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

Stanford Investigator(s)

Paul D. Blumenthal, MD, MPH
Paul D. Blumenthal, MD, MPH

Professor of Obstetrics and Gynecology (Gynecology-Family Planning) at the Stanford University Medical Center, Emeritus


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 and
   has not had 2 normal menstrual cycles since the last injection;

   7. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time
   during 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

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

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.


drug: VeraCept


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Batham