Clinical trial: A Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women (NCT02451826)

Eligibility criteria:
Inclusion Criteria:

          -  Not at risk for pregnancy based on one of the following: a. subject has undergone
             sterilization; b. subject is monogamous and her male partner has undergone
             sterilization

          -  Have regular menstrual cycles of 25-35 days duration

          -  Have an intact uterus and both ovaries

          -  Will be able to comply with the protocol

          -  Capable of giving informed consent

        Exclusion Criteria:

          -  Women participating in another clinical trial

          -  Women not living in the catchment area of the clinic

          -  Known hypersensitivity to progestins or antiprogestins

          -  Known hypersensitivity to silicone rubber

          -  Any chronic disease

          -  All contraindications to oral contraceptive use, including: a. Thrombophlebitis or
             thromboembolic disorders; b. Past history of deep vein thrombophlebitis or
             thromboembolic disorders; c. Past or current cerebrovascular or coronary artery
             disease; d. Migraine with focal aura; e. Known or suspected carcinoma of the breast;
             f. Carcinoma of the endometrium or other known or suspected estrogen-dependent
             neoplasia; g. Undiagnosed abnormal genital bleeding; h. Cholestatic jaundice of
             pregnancy or jaundice with prior pill use; i. Hepatic adenomas or carcinomas; j. Known
             or suspected pregnancy

          -  Desire to get pregnant during the study (through the use of reproductive technology
             for sterilized women or vasectomy reversal for sterilized partners)

          -  Breastfeeding

          -  Undiagnosed vaginal discharge or vaginal lesions or abnormalities

          -  Women with a current abnormal Pap: In accordance with the Bethesda system of
             classification: smear suggestive of high-grade pre-cancerous lesion(s), including
             HGSIL, are excluded; Women with LGSIL or ASCUS/high-risk HPV positive may participate
             if further evaluated with colposcopy and biopsy and no evidence of a lesion with a
             severity > CIN I is present and/or endocervical curettage is negative; Women with a
             biopsy finding of CIN I should have follow up for this finding per standard of care;
             women are excluded it treatment is indicated.

          -  Known benign or malignant liver tumors; known active liver disease

          -  Cancer (past history of any carcinoma or sarcoma)

          -  Medically diagnosed severe depression currently or in the past

          -  Known or suspected alcoholism or drug abuse

          -  Abnormal serum fasting clinical chemistry values

          -  Women with known abnormal thyroid status

          -  Women with known impaired hypothalamic-pituitary-adrenal reserve

          -  Average diastolic BP > 85 mm or systolic BP >135 mm Hg after 5-10 minutes rest

          -  Body mass index (BMI) > 30.0 (or ≤18)

          -  Smoking in women who will be 35 years during the course of the trial; women < 35 years
             who smoke greater than 15 cigarettes per day must be evaluated by the PI for inclusion
             based on risk factors that would increase their risk for CVD and thromboembolism, e.g.
             lipid levels, glucose level, BP, BMI, family history of CVD at a young age.

          -  Women with severe cystoceles or rectoceles

          -  Use within the past 2 months of any implanted hormonal contraceptives including Mirena
             [progestin containing intrauterine system (IUS)] or Norplant (subdermal implant
             delivering LNG). NOTE: Removal of implanted hormonal contraceptives must have been for
             personal reasons unrelated to the purpose of enrollment in this study.

          -  Current use of a non-hormone containing IUD. NOTE: Removal of an IUD must have been
             for personal reasons unrelated to the purpose of enrollment in this study.

          -  Use of injectable contraceptives during the previous 3 months (e.g. Cyclofem) or 6
             months (e.g. DMPA).

          -  Women who do not have at least two progesterone measurements during the control cycle
             of ≥10nmol/L will be excluded from further participation in the study (See Section
             13.4.1)
Female
Accepts Healthy Volunteers
Subject must be at least 21 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? 0