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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD115770-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relugolix | Experimental | Participants will take Reugolix for 10 days starting at the midluteal time point (6-9 days after "high fertility" based on ovulation test) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gonadotropin Releasing Hormone Antagonists Relugolix | Drug | Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cervical mucus scores | Average cervical mucus scores at each study time point | 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]) |
| Single cell transcriptome analysis | Single cell transcriptome analysis comparing changes across menstrual time points | 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 | Proteomic analysis of mucus including Mucin concentration | 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]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Women's Health Research Unit Recruitment Line | Contact | 503-494-3666 | whru@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Leo Han, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| C561634 | relugolix |
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All participants will receive Relugolix for 10 days starting at the midluteal time point
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