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Hormone Therapy

Idiopathic Pelvic Pain for Pelvic Pain

Phase 2

Waitlist Available

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Idiopathic pelvic pain (40 participants): Self-report an average non-menstrual pelvic pain rating of ≥ 2/10 over the past 6 months. Not have received a prior diagnosis attributed to a secondary cause

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

"This trial will study why Relugolix-Combination Therapy works differently for different people in reducing unexplained pelvic pain. They will use imaging techniques and sensory testing to find out."

Who is the study for?

This trial is for women with severe endometriosis (stage III-IV) or those with unexplained pelvic pain, both experiencing a certain level of pain over the past 6 months. Participants should not be overweight, have blood clotting issues, liver disorders, allergies to REL-CT ingredients, hormone-sensitive cancers, metal in their body that affects MRI scans, thyroid problems or other specific health conditions.Check my eligibility

What is being tested?

The study tests Relugolix combination therapy's effectiveness on pelvic pain using advanced uterine imaging and sensory testing. It aims to understand why this treatment works well for some women but not others by looking at how their bodies respond differently.See study design

What are the potential side effects?

Possible side effects of Relugolix combination therapy may include hormonal changes like hot flashes or mood swings due to estradiol and norethisterone acetate components. Other common medication-related side effects could occur as well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had pelvic pain not related to periods, averaging 2/10 or more, for the past 6 months without a known cause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Correlation between post-treatment pelvic pain and baseline sensory hypersensitivity Z-score.

Correlation between post-treatment pelvic pain and baseline uterine contraction frequency

Trial Design

2Treatment groups

Experimental Treatment

Group I: Idiopathic Pelvic PainExperimental Treatment1 Intervention

Participants with Idiopathic Pelvic Pain must: 1. Self-report an average non-menstrual pelvic pain rating of ≥ 4/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months. 2. Not have received a prior diagnosis attributed to a secondary cause (e.g., leiomyoma, endometriosis). Participants will be instructed to start taking Relugolix-combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate) within 7 days of their period starting, at the same time every day for the next 6 months.

Group II: Endometriosis:Experimental Treatment1 Intervention

Participants with Endometriosis: 1. Must self-report an average non-menstrual pelvic pain rating of ≥ 4/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months. 2. Have a previously confirmed surgical diagnosis of stage III-IV endometriosis, indicating potential remission. Participants will be instructed to start taking Relugolix-combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate) within 7 days of their period starting, at the same time every day for the next 6 months.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,598 Total Patients Enrolled

2 Trials studying Pelvic Pain

433 Patients Enrolled for Pelvic Pain

PfizerIndustry Sponsor

4,571 Previous Clinical Trials

10,923,229 Total Patients Enrolled

1 Trials studying Pelvic Pain

62 Patients Enrolled for Pelvic Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research study open to individuals below 20 years of age?

"Individuals aged 18 to 35 are eligible for participation based on the study's specific age requirements."

Answered by AI

What risks are associated with Idiopathic Pelvic Pain in individuals?

"Idiopathic Pelvic Pain is being assessed in a Phase 2 trial, with our evaluation rating its safety at level 2. This indicates that while some safety data exists, there is currently no evidence supporting efficacy."

Answered by AI

Are there currently ongoing efforts to enroll patients in this clinical trial?

"Information available on clinicaltrials.gov states that the present medical investigation is not open for patient enrollment. Originally posted on April 5th, 2024 and last amended on February 20th, 2024, this study is one of many across various fields currently seeking participants; however, there are no openings in this particular trial presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment

Kevin Hellman 2024. "Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06279195.