Health TrialsbyHealthPanel

Insights in Endocervical Mucus Secretion

ConditionCervical Mucus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age21-40
SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Normal menstrual cycles of 25-35 days in length for at least the previous 3 cycles

BMI >18 and <35

Serum p4 >= 3 ng/ml on single sample collected between days 18-25 of self-reported menstrual cycle

Flexible schedule allowing blood draws on less than 48 hour notice

Disqualifiers

Oral contraceptive use or other hormone supplement within the preceding 2 months

Current cervical infection

Evidence of abnormal cervical cytology

Use of any IUD for contraception

Trial design

Design model

Single group

Treatments tested in this trial

  • Gonadotropin Releasing Hormone Antagonists Relugolix

    Drug

    Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: RelugolixExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cervical mucus scores

Average cervical mucus scores at each study time point

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])
2

Single cell transcriptome analysis

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])
3

Proteomic analysis

Proteomic analysis of mucus including Mucin concentration

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])

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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