Principal Investigator: Lori Gawron
Keywords: Copper IUD , Family Planning , Women's Health , contraception Department: Obstetrics And Gynecology (Dept)
IRB Number: 00107959
Specialty: OB/Gyn, General
Sub Specialties: Contraception and Family Planning
Recruitment Status: Active, not recruiting

Contact Information

Amy Orr
amy.orr@hsc.utah.edu
801-213-2774

Brief Summary

Objectives and Endpoints

Objectives

The primary objective of the study is to assess the contraceptive efficacy (prevention of pregnancy) of VeraCept.

The secondary objectives of the study are to assess the following for VeraCept:

*Safety and tolerability

*Return to fertility after VeraCept removal, only for subjects requesting VeraCept removal to become pregnant

Endpoints

Primary Endpoint

The primary endpoint is the contraceptive efficacy through 3 years of use, as assessed by the Pearl Index.  The Pearl Index will be calculated for Years 1, 2 and 3 as well as cumulatively through Year 3.

Secondary Endpoints

Secondary endpoints include:

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.

The primary and secondary endpoints for the study will be reviewed after 200 subjects have completed 3 years of treatment to assess if the data supports the filing of an NDA for approval of an indication with 3 years of use.

 

Inclusion Criteria

Subjects must meet all of the following criteria to participate in this study:

  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 must be in compliance with cervical cancer screening guidelines per the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without evidence of disease.  Subjects who are age 21-24, at time of informed consent, must have a normal papanicolaou test (Pap), atypical squamous cells of undetermined significance (ASC-US), or low-grade squamous intraepithelial lesion (LSIL).  Subjects who are 25 or older at the time of informed consent with ASC-US results must also have a negative high-risk human papilloma virus (HPV) test result within the appropriate screen timeframe, and prior to study IUS insertion. Alternatively, the subject must have had a colposcopy performed within the appropriate screen timeframe per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines, and prior to study IUS 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). 
  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

A subject will be excluded from participating in the study if any of the following conditions apply:

  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 IUS that has not been removed by the time the study IUS is placed;
  4. History of previous IUS complications, such as perforation, expulsion, or pregnancy with IUS in place;
  5. Pain with current IUS;
  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 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:
    1. Submucosal uterine leiomyoma
    2. Asherman’s syndromes
    3. Pedunculated polyps
    4. Bicornuate uterus
    5. Didelphus or uterine septa
  14. Any distortions of the uterine cavity (e.g. fibroids), in the opinion of the investigator, are likely to cause issues during insertion, retention or removal of the IUS;
  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 or unresolved acute cervicitis or vaginitis;
  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 or LevoCept study; 
  22. subject has been enrolled in a previous VeraCept or LevoCept study where VeraCept or LevoCept placement was successful or attempted (replaces 21 for PK sub-study subjects only)
  23. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
  24. 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;
  25. Study staff or a member of the immediate family of a study staff;
  26. Subject is <4 weeks post-pregnancy (postpartum, spontaneous or induced abortion).

Note: VeraCept can be inserted on any day of the menstrual cycle using the Centers for Disease Control and Prevention (CDC) U.S. Selected Practice Recommendations for Contraceptive Use, 2016[10] as guidance to avoid an undetected pregnancy (see Box 2 below from the CDC Selective Practice Recommendations and a copy is located in the study reference manual provided to the site).  If a subject has a previously inserted IUS and has pain from that IUS removal, then the insertion of VeraCept should not occur until the pain has resolved.

Post Pregnancy Guidelines: Subjects who were recently pregnant must have a urine pregnancy test performed no sooner than 4 weeks post-pregnancy.  If a subject has not had 2 normal menses since the end of a pregnancy, the study IUS may be placed if her hCG is negative and she has been on a reliable method of contraception (e.g. pills, patch, ring) that was started within 2 weeks post-pregnancy or has been on this reliable method for 4 weeks.  If the urine hCG is still positive, investigators can obtain two quantitative hCG tests that must demonstrate declining hCG values at least 1 day apart. 

 BOX 2. How to be reasonably certain that a woman is not pregnant[10]

A health care provider can be reasonably certain that a woman is not pregnant if she has no symptoms or signs of pregnancy and meets any one of the following criteria:

• is ≤7 days after the start of normal menses

• has not had sexual intercourse since the start of last normal menses

• has been correctly and consistently using a reliable method of contraception*

*If condoms are being used, a double barrier method must be used (e.g. condoms + spermicide)