Clinical trial: Alternating Urine Redox Status Of Consecutive Menstrual Cycles (NCT04157309)

Eligibility criteria:
Inclusion Criteria:

          1. Female subject, between the years 18-30, at the time of consent.

          2. Subject is willing to participate and is capable of giving informed consent. (Note:
             Consent must be obtained prior to any study-related procedures.)

          3. Subject must be willing to comply with all study procedures and must be available to
             participate for the duration of the study.

          4. Subject agrees to avoid alcohol, unapproved medications (prescription, OTC, or other),
             marijuana products, and illicit substances for 3 days prior to each urine collection.

        Exclusion Criteria:

          -  1. Subject is pregnant, or trying to or planning to become pregnant during the study.

             2. Subject was pregnant within 1 year of beginning study, regardless of the outcome of
             pregnancy.

             3. Subject who is breastfeeding. 4. Subject who is not menstruating for any reason or
             plans to undergo or change circumstances that might affect menstruation (e.g., certain
             athletic training regimens, significant dietary changes).

             5. History of recent or current irregular menstrual cycles (as self-reported by the
             subject).

             6. Subject reports she has been told by a medical professional that she is not
             ovulating (i.e., has anovulatory periods) at any time during the previous 12 months.

             7. Subject is using or planning to use any method to regulate her periods. 8. Subject
             smokes (includes tobacco and marijuana) or vapes. 9. By history, subject has medical
             problems that might influence the results of the study, such as endocrinologic, renal,
             or hormonal problems.

             10. Known polycystic ovarian syndrome (by history). 11. Subject is taking or planning
             to take hormones or hormone- enhancing/manipulating pharmaceuticals (including
             "morning after pill" [levonorgestrel], birth control pills, Clomid [clomiphene
             citrate], Femara [letrozole], Cialis [tadalafil]*, Viagra [sildenafil]* and similar
             medications) and/or agents to influence hormonal status such as herbal products or
             nutritional supplements. (*Not approved for use and should be avoided by women.) 12.
             Subject is using or planning to use hormonal contraceptives of any type, including
             oral contraceptives and intrauterine devices.

             13. Subject is using or planning to use hormonal therapies for acne vulgaris or other
             conditions, including spironolactone, flutamide, metformin, or oral contraceptives
             used as acne therapies, including Ortho Tri-Cyclen (combination of norgestimate and
             ethinyl estradiol [EE]), Estrostep (combination of norethindrone acetate and EE), and
             Yaz/Yasmin (combination of drospirenone and EE).

             14. Subject is using or planning to use estrogen products, including topicals/creams,
             for any purpose.

             15. Subject is using or planning to use androgens or anabolic steroids (e.g.,
             stanazolol/danazol) for any reason, including for training or athletic purposes..

             16. Subject has attempted or taken IVF or IUI treatment within the prior six months.

             17. Subject has uncontrolled diabetes or other significant medical disorder that
             might, in the investigator's opinion, preclude completion of the study or suggest that
             an exclusion criterion will ensue.

             18. Subject reports difficulty handling biologic fluids, specifically urine, or gives
             other reasons why she is hesitant to participate.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Entailment