Relugolix for Cervical Mucus

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Must not be taking: Oral contraceptives, Hormone supplements

Disqualifiers: Diabetes, PCOS, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called Relugolix to assess its effects on cervical mucus, which is important for fertility and reproductive health. Researchers will collect samples at various points during the menstrual cycle to observe changes. Women with regular menstrual cycles, who are in good health and not using hormonal birth control, may be suitable candidates for this trial. Participants should be comfortable taking medication and undergoing regular blood tests. As a Phase 4 trial, Relugolix has already received FDA approval and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used oral contraceptives or hormone supplements in the last 2 months, or if you're currently using an IUD or long-acting hormonal contraceptives.

What is the safety track record for this treatment?

Research has shown that relugolix is generally well-tolerated. In earlier studies, the most common side effects were mild, including hot flashes, headaches, mood swings, vaginal dryness, and some weight gain. These effects were usually not serious. Additionally, other clinical trials have tested relugolix for different conditions, further confirming its safety. Overall, the treatment appears safe, with manageable side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Relugolix is unique because it targets the hormonal pathways in a novel way, which could impact cervical mucus. Most treatments for related conditions focus on regulating hormones with estrogen and progestin combinations, but Relugolix works as a gonadotropin-releasing hormone (GnRH) antagonist. This means it directly reduces the production of certain hormones, offering potentially faster and more targeted relief. Researchers are excited because it might lead to quicker results and fewer side effects compared to traditional hormone therapies.

What is the effectiveness track record for Relugolix in treating cervical mucus?

Research has shown that relugolix is effective for several women's health issues. Specifically, studies have found that relugolix can reduce pain and improve daily life for women with endometriosis by blocking certain hormones that cause pain and other symptoms. In this trial, participants will take relugolix to study its effects on cervical mucus. Although the current trial focuses on cervical mucus, relugolix's proven success in treating hormone-related conditions suggests it could be effective here too. Overall, relugolix has a strong track record in managing hormone-related problems, supporting its potential usefulness in this study. ^{4 6 7 8 9}

Who Is on the Research Team?

Leo Han, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for women with a BMI between 18 and 35, normal menstrual cycles, no recent infertility treatments (except male factor issues), not breastfeeding or pregnant in the last six months, non-smokers, without diabetes or PCOS. Participants must be willing to use condoms and avoid hormonal contraceptives during the study.

Inclusion Criteria

BMI >18 and <35

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

No objections to refraining from intercourse the night before any sampling and willing to use condoms during vaginal intercourse

Exclusion Criteria

Breastfeeding in the past 2 months

History of, or self-reported, substance abuse

Smoker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Follicular Phase Sampling

Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab are collected during the early follicular phase

3-5 days

1 visit (in-person)

Peri-ovulation Sampling

Participants monitor for peri-ovulation using an ovulation test and samples are collected

9-14 days following the start of menstruation

1 visit (in-person)

Mid-luteal Phase and Treatment

Participants begin taking relugolix for 10 days and samples are collected at the mid-luteal time point

6-9 days after 'high fertility' on ovulation test

1 visit (in-person)

Ovarian Suppression Sampling

Samples are collected upon stoppage of relugolix

9-11 days following relugolix initiation

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Relugolix

Trial Overview The study tests how an oral gonadotropin-releasing hormone antagonist affects cervical mucus secretion. Women will take this medication and provide samples of blood, endocervical mucus and tissue, as well as vaginal swabs at four different times in their cycle.

How Is the Trial Designed?

Group I: Relugolix Experimental Treatment 1 Intervention

Participants will take Reugolix for 10 days starting at the midluteal time point (6-9 days after "high fertility" based on ovulation test)

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07111247

NCT07111247 | Insights in Endocervical Mucus Secretion Single arm interventional study looking at biological outcomes at 4 time points throughout the cycle before and after taking an oral ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10905503/

Two-year efficacy and safety of relugolix combination therapy ... For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis.

3. go.drugbank.com go.drugbank.com/drugs/DB11853

Relugolix: Uses, Interactions, Mechanism of Action Based on its mechanism of action and data from animal studies, relugolix may result in fetal harm if administered to pregnant females - male patients with ...

4. ichgcp.net ichgcp.net/clinical-trials-registry/548100-insights-in-endocervical-mucus-secretion

Understanding Cervical Mucus Changes During the Menstrual ... After completing relugolix treatment. The study aims to analyze three main aspects of cervical mucus: its physical properties (through ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17371516/

Efficacy of cervical mucus observations plus electronic ... Main outcome measures: Correct- and typical-use unintended pregnancy rates. Results: There were a total of 26 unintended pregnancies, 3 with correct use.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12489269/

Safety and efficacy of relugolix combination therapy in ... In all women, the most frequent side effects of treatment were mild vasomotor symptoms, mild headache, mood swings, vaginal dryness, weight gain ...

7. abmole.com abmole.com/literature/relugolix-msds.html?srsltid=AfmBOopgUTK0CT2UbArhtWKA572kWpIzbO-VvKnPZzuoriSkFLBOylCV

Material Safety Data Sheet of Relugolix Material Safety Data Sheet of Relugolix contains identification of substance and details of the supplier of the safety data sheet.

8. ema.europa.eu ema.europa.eu/en/documents/product-information/ryeqo-epar-product-information_en.pdf

Ryeqo, INN-Relugolix-Estradiol-Norethisterone acetate Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/214846s002lbl.pdf

MYFEMBREE® (relugolix, estradiol, and norethindrone ... The safety of MYFEMBREE was evaluated in two placebo-controlled clinical trials, Study L1. (LIBERTY 1) and Study L2 (LIBERTY 2), in women with heavy menstrual ...