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

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;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.