Clinical trial: Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception (NCT02446821)

Eligibility criteria:
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.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 0