A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone
Sponsor: |
Estetra SPRL |
Enrolling: |
Female Patients Only |
Study Length: |
1 Years |
Clinic Visits: |
7 |
IRB Number: |
AAAQ9875 |
U.S. Govt. ID: |
NCT02817841 |
Contact: |
Connie Colon: 212-317-4754 / cc3238@cumc.columbia.edu |
This study is studying the effectiveness and safety of a new birth control pill. The pill contains two hormones, drospirenone (a progestin) and estetrol (an estrogen), which combine to prevent pregnancy. Scientists think that estetrol may be safer and have more benefits than other estrogen hormones. The study lasts about one year, and you will come in for 7 study visits. Throughout the study you will take the birth control pill daily and rely on it as your only form of birth control. You will record a daily diary that contains information about your pill intake and other questions.
This study is closed
Investigator
Carolyn Westhoff, MD
Are you a healthy woman aged 18-50? |
Yes |
No |
Are you at risk for pregnancy (d0 you have heterosexual vaginal intercourse at least once a month and are not sterilized)? |
Yes |
No |
Are you willing to use hormonal birth control pill for about 1 year as your only method of birth control? |
Yes |
No |
Do you have a history of blood clots, liver disease, heart disease, or breast cancer? |
Yes |
No |