Clinical trial: Open-Label Extension Study to ZPE-202 (NCT01961908)

Eligibility criteria:
Inclusion Criteria:

          -  Successful completion of protocol ZPE-202, or subject who withdrew from ZPE-202 for
             lack of efficacy after completion of at least 28 days of double-blind treatment (after
             Visit 3)

          -  Agreement not to attempt to become pregnant during the trial

          -  Women of child-bearing potential must be willing to use double-barrier contraception
             during the study and for 30 days after discontinuation of study medication. Acceptable
             double-barrier methods are: male condom with spermicide; male condom with diaphragm;
             diaphragm containing spermicide plus additional intra-vaginal spermicide

          -  Has a negative pregnancy test at Visit 1

          -  Is available for all treatment and follow-up visits

        Exclusion Criteria:

          -  Subject is pregnant or lactating or is attempting or expecting to become pregnant
             during the 6-7 month study period

          -  Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids,
             dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to Visit
             1.

          -  Presence of intramural fibroids that impact the endometrial stripe, submucosal
             fibroids (any size), or endometrial polyps. Subserosal and intramural fibroids with no
             impact on the endometrial stripe are acceptable.

          -  Presence of endometrioma(s)

          -  Present history or condition that causes non-endometriosis related dyspareunia (e.g.
             vulvar vestibulitis).

          -  Past or present history of thrombophlebitis or thromboembolic disorders.

          -  Known or suspected carcinoma of the breast or reproductive organs.

          -  Cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance
             (ASCUS) associated with high-risk human papilloma virus (HPV) or Low/High Grade
             Squamous Intraepithelial Lesion (LGSIL or HGSIL).

          -  Known active infection with HIV, Hepatitis A, B or C.

          -  Endometrial stripe ≥18 mm in thickness at Visit 1.

          -  Subject is currently taking cimetidine or spironolactone.

          -  Clinically significant abnormal findings on screening examination and laboratory
             assessments or any condition which in the opinion of the investigator would interfere
             with the participant's ability to comply with the study instructions or endanger the
             participant if she took part in the study.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 47 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