Evaluation of the Effectiveness, Feasibility, Safety and Tolerability of the ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception
Sponsor: |
ContraMed, LLC |
Enrolling: |
Female Patients Only |
Study Length: |
13 Months |
Clinic Visits: |
6 |
IRB Number: |
AAAP4110 |
U.S. Govt. ID: |
NCT02446821 |
Contact: |
Carolyn Westhoff: 212-305-4805 / clw3@columbia.edu |
There are over 62 million US women in their child-bearing years, ages 15-44. Thirty-eight million use some form of contraception which included permanent sterilization (tubal ligation or vasectomyin male partner), contraceptive implants, intrauterine devices, injections, pills, patches, vaginal spermicides, and behavioral methods such as coitus interrupts and fertility awareness. TheVeraCept Intrauterine Copper Contraceptive is designed as a birth control device. The VeraCept Intrauterine Copper Contraceptive device consists of a Nitinol (nickel/titanium) spring with copper sleeves at both the distal arms and proximal stem. It is shaped such that upon placement In the uterus, the Nitinol spring positions itself at the fundus (top portion of the uterus opposite from the cervix), with the copper sleeved arms near the ostia (opening) of the fallopian tubes and copper sleeved stem at or near the internal os (opening) of the cervix. The amount of copper utilized in VeraCept is 175mm2 exposed surface area. This compares to the typical 380mm2 of coppersurface area for the standard plastic TCu380 IUD. Because of its spring action, VeraCept can place concentrated amounts of copper in anatomically relevant positions with the uterus, designed to result in a more efficient profile for contraception. The study device is placed using a simple one step introducer containing the preloaded and sterile study device. It is retrieved with a standard retrieval thread. A Pilot Study in a population of parous women enrolled at a single site demonstrated the safe use of the study device in approximately 463 subjects total in two phases of the study. VeraCept was successfully placed in all enrolled subjects with no peri-procedural adverse event and without the use of anesthetics, pre-medication or mechanical dilation. In thisinitial experience VeraCept satisfied the objectives of providing a safe, easy to place, comfortable low-dose copper contraceptive that is highly tolerated.
This study is closed
Investigator
Carolyn Westhoff, MD
Do you have regular menstrual cycles? |
Yes |
No |
Are you sexually active with a male partner who has not had a vasectomy? |
Yes |
No |
Are you seeking to avoid pregnancy for the next 12 months? |
Yes |
No |