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

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

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

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;

4. History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place;

5. 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;

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 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

12. Any history of gestational trophoblastic disease with or without detectable elevated ß-hCG levels, or related malignant disease;

13. 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

14. 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;

15. Current or recent (within the last 3 months) pelvic infection (cervix, endometrium, or fallopian tubes), or mucopurulent cervicitis;

16. High risk for STDs (e.g., multiple sexual partners);

17. Known or suspected AIDS;

18. Known intolerance or allergy to nickel or copper, including Wilson's Disease;

19. Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study;

20. Subject had VeraCept placed previously or had 2 attempts at placement;

21. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;

22. 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.