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 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction