Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04157309
Other study ID # HUM00171526
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 6, 2020
Est. completion date January 4, 2021

Study information

Verified date March 2021
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will involve the collection and analysis of urine samples from non-pregnant women to determine the existence of alternating redox status between two consecutive menstrual cycles.


Description:

The Sponsor believes there is variability in the relative redox status in women's urine across menstrual cycles. This validation study will involve the collection and analysis of urine samples from non-pregnant women to determine the existence of alternating redox status between two consecutive menstrual cycles. If the hypothesis is proved, future research could examine if there are related fertility issues.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 4, 2021
Est. primary completion date January 4, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Urobiologics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Redox potential of urine The redox potential will be measured over two consecutive cycles to determine the variability in the relative redox status in women's urine. 12 months
See also
  Status Clinical Trial Phase
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT06258902 - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed NCT05487196 - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia Phase 2
Completed NCT03750968 - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects Phase 2
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT06069869 - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06069856 - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06079918 - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania Phase 3
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A