Clinical trial: Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle (NCT02817464)

Eligibility criteria:
Inclusion Criteria:

          -  has regular menstrual cycle (24 to 35 days)

          -  is at low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, in
             monogamous relationship with vasectomized partner, or using non-hormonal IUD)

          -  is in good general health as determined by a medical history and physical examination

          -  is not pregnant and does not have desire to become pregnant in the subsequent 36
             months

          -  has had a normal mammogram within the last year (for Part 1 only)

               -  additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  has hypertension:

               -  systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg

               -  vascular disease

          -  has current or history of ischemic heart disease

          -  has history of stroke

          -  has history of thromboembolic event

          -  has systemic lupus erythematosus

               -  positive (or unknown) antiphospholipid antibodies

               -  severe thrombocytopenia

          -  has rheumatoid arthritis on immunosuppressive therapy

          -  has migraine with aura

          -  has unexplained vaginal bleeding

          -  has diabetes

          -  has strong family history of breast cancer (defined as one or more first degree
             relatives, breast cancer occurring before menopause in three or more family members,
             regardless of degree of relationship, and any male family member with breast cancer),
             or current or history of breast cancer, or undiagnosed mass detected by breast exam

          -  has current or history of cervical cancer

          -  has severe cirrhosis (decompensated) or liver tumors

          -  has known significant renal disease

          -  used Depo-Provera Contraceptive Injection or Depo-subcutaneous Provera 104 (DMPA)
             products in the past 12 months

          -  used any of the following medications within 1 month prior to enrollment:

               -  any investigational drug

               -  prohibited drugs per protocol

               -  oral contraceptives, contraceptive ring or patch

               -  levonorgestrel intrauterine system (LNG IUS) or contraceptive implant

          -  used a combined injectable contraceptive in the past 6 months

          -  less than 3 months since the end of last pregnancy

          -  currently lactating

          -  is using or plans to use prohibited drugs per protocol in the next 18 months

          -  has known sensitivity to MPA or inactive ingredients

          -  has a plan to move to another location in the next 24 months

          -  in the opinion of the investigator, potentially at elevated risk of HIV infection (eg,
             HIV -positive partner, IV drug use by self or by partner)

               -  additional criteria apply, please contact the investigator for more information
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 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