Clinical trial: Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge (NCT01107093)

Eligibility criteria:
Inclusion Criteria:

          -  Women of good general health aged 18 - 35 years

          -  Not at risk of pregnancy

          -  Regular menstrual cycles of 24-35 days duration

          -  Not pregnant

          -  Intact uterus and ovaries

          -  Haemoglobin ≥ 11 g/dl

          -  Normal laboratory tests and normal TSH

          -  Willing to abstain from any use of hormonal contraception until study completion

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

          -  Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage
             or induced abortion

          -  Able to give voluntary, written informed consent, and agreeing to observe all study
             requirements for 5 complete menstrual cycles

        Exclusion Criteria:

          -  Current participation in any other trial of an investigational medicine

          -  Known hypersensitivity to the ingredients of the test active substances or excipients

          -  Suspected hyperplasia or carcinoma of the endometrium

          -  Current pregnancy as confirmed by positive serum beta-hCG at screening

          -  Desire to get pregnant before the planned end of the study participation

          -  Currently breastfeeding

          -  Abnormal Pap smear

          -  Cancer (past history of any carcinoma or sarcoma)

          -  Known or suspected alcoholism or drug abuse

          -  Abnormal thyroid status

          -  Body mass index > 32

          -  Current use of hormonal contraception

          -  Use of hormonal emergency contraception since last menstrual period

          -  Severe asthma insufficiently controlled by oral glucocorticoids

          -  Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose
             malabsorption
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years

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