Clinical trial: Safety and Efficacy of CDB-2914 for Emergency Contraception (NCT00411684)

Eligibility criteria:
Inclusion Criteria:

          -  Aged 18 years or more

          -  Menstruating women with regular menstrual cycle between 24 and 35 days and
             intra-individual variations less than or equal to 5 days

          -  Request emergency contraception between 48 hours and 120 hours after unprotected
             intercourse as defined by lack of contraceptive use, or condom breakage (including
             condoms lubricated with spermicide) or other barrier contraceptive method failure

          -  No current use of hormonal contraception and having had at least one complete
             menstrual cycle (2 menses) since having stopped hormonal contraception

          -  For women with a recent history of Depo Provera use, the most recent injection must
             have been at least 9 months before study entry and followed by at least one complete
             menstrual cycle (2 menses)

          -  Willing to not use hormonal methods of contraception until study completion

          -  At least one complete menstrual cycle (2 menses) post delivery, miscarriage or
             abortion

          -  Able to provide informed consent in English

          -  Give voluntary, written informed consent, and agree to observe all study requirements
             (the subject needs to be available for follow-up over the next 6 weeks)

          -  Willing to abstain from further acts of unprotected intercourse during participation
             in the study and until pregnancy status has been ascertained

        Exclusion Criteria:

          -  One or more acts of one unprotected intercourse more than 120 hours before requesting
             emergency contraception in the current cycle

          -  All acts of unprotected intercourse (in the current cycle) within 48 hours of
             presentation

          -  Currently pregnant as confirmed by positive HSUP test performed at screening

          -  Currently breast-feeding

          -  Current use of hormonal contraception

          -  Use of hormonal emergency contraception since last menstrual period

          -  Current use of IUD

          -  Tubal ligation

          -  Partner with a vasectomy

          -  Unsure about the date of the last menstrual period

          -  Severe asthma insufficiently controlled by oral glucocorticoid

          -  Currently enrolled in any other trial of an investigational medicine
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? Contradiction