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Selective Progesterone Receptor Modulator

Ulipristal for Endometriosis

Phase 4
Waitlist Available
Led By Serdar Bulun
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights

Study Summary

The aim of this research is to assess the benefit of a medication (ulipristal) for alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.

Eligible Conditions
  • Endometriosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Pelvic Pain
Secondary outcome measures
Pain with sexual intercourse
Serum hormone levels
Vaginal bleeding
Other outcome measures
Pain with bowel movements

Side effects data

From 2015 Phase 3 trial • 451 Patients • NCT01629563
13%
headache
8%
hot flush
5%
influenza
4%
pelvic pain
4%
breast pain/breast tenderness/breast disconfort
3%
vertigo
3%
nausea
3%
nasopharyngitis
3%
fatigue
2%
hypertension
2%
vaginal discharge
2%
back pain
2%
abdominal pain
2%
acne
2%
anxiety
2%
aneamia
2%
tonsillitis
2%
weight increased
2%
Menorrhagia
2%
blood creatine phosphokinase increased
1%
cough
1%
cystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ulipristal Acetate (PGL4001) 5mg
Ulipristal Acetate (PGL4001) 10mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: UlipristalExperimental Treatment1 Intervention
25 patients with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ulipristal
FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,592 Previous Clinical Trials
918,017 Total Patients Enrolled
3 Trials studying Endometriosis
742 Patients Enrolled for Endometriosis
Serdar BulunPrincipal InvestigatorNorthwestern University, Northwestern Memorial Hopsital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Ulipristal for Endometriosis-related Pelvic Pain
Serdar Bulun 2015. "Ulipristal for Endometriosis-related Pelvic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02213081.
All > Endometriosis
~2 spots leftby May 2025
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