Oregon Health & Science University
Portland, Oregon, 97239, United States
Location status: Recruiting
Location contact
Leo Han, MD
CONTACT
NCT Number: NCT07111247
Single arm interventional study looking at biological outcomes at 4 time points throughout the cycle before and after taking an oral gonadotropin-releasing hormone antagonist (gnRH). Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected.
Interested in participating?
Request Info21 year–40 year
Female
Interventional
Phase 4
Portland, Oregon, 97239, United States
Location status: Recruiting
Leo Han, MD
CONTACT
This study will enroll participants and obtain biological samples at 4 time points. The study will begin on the first day of menstruation following enrollment. Patients will monitor for peri-ovulation using an ovulation test that monitors for urinary metabolites for luteinizing hormone (LH). At the midluteal time point for sampling (days 6-9 after "high fertility" on ovulation test) subjects will begin taking an oral gonadotropin-releasing hormone antagonist (gnRH) (relugolix) for 10 days. Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected during the early follicular phase (3-5 days following the start of menstruation), peri-ovulation (9-14 days following the start of menstruation based on estriol glucuronide (E3G) urinary metabolite), mid-luteal (6-9 days following mid-cycle draw), and upon stoppage of relugolix (9-11 days following relugolix initiation).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.
Time frame: Cervical mucus will be collected and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])
Average cervical mucus scores at each study time point
Time frame: Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])
Single cell transcriptome analysis comparing changes across menstrual time points
Time frame: Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])
Proteomic analysis of mucus including Mucin concentration
Contact information is provided by the study sponsor or research team.
Oregon Health and Science University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07248046
Artifical Intelligence, Body Temperature
Ottawa, Ontario, Canada
View Trial DetailsNCT06396221
Cervical Mucus, Serum Hormonal Profile
Bangkok, Thailand
View Trial DetailsNCT06396208
Cervical Mucus, Serum Hormonal Profile
Bangkok, Thailand
View Trial Details