Trial Outcomes & Findings for Ulipristal for Endometriosis-related Pelvic Pain (NCT NCT02213081)

Results Overview

Scores were collected daily and averaged together for each period

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Patients will document self-reported daily pain scores via visual analogue scale(0 to10 where 0 is no pain and 10 is worst pain)for one month prior to starting treatment (1 month),while receiving treatment (3 months) after cessation of treatment (1 month)

Results posted on

2024-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Ulipristal 1 patient with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies received 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ulipristal for Endometriosis-related Pelvic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ulipristal n=1 Participants 1 patient 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. Ulipristal: Patient will take 15mg every other day, or every 4 days per week.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Patients will document self-reported daily pain scores via visual analogue scale(0 to10 where 0 is no pain and 10 is worst pain)for one month prior to starting treatment (1 month),while receiving treatment (3 months) after cessation of treatment (1 month)

Scores were collected daily and averaged together for each period

Outcome measures

Outcome measures
Measure	Ulipristal n=1 Participants 1 patient 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.
Pelvic Pain Prior to starting therapy	3.5 units on a scale Standard Error 0.57
Pelvic Pain During therapy	0.2 units on a scale Standard Error 0.06
Pelvic Pain After cessation of therapy	3.9 units on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: 5 months

Patient will record the # of tampons or pads they use each week while enrolled in the study (1 month pre-medication, 3 months during medication, 1 month after medication).

Outcome measures

Outcome measures
Measure	Ulipristal n=1 Participants 1 patient 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.
Vaginal Bleeding Prior to therapy	3 pads or tampons
Vaginal Bleeding During therapy	0 pads or tampons
Vaginal Bleeding After cessation of therapy	3 pads or tampons

SECONDARY outcome

Timeframe: 5 months

Population: The one patient in our study was not sexually active during her enrollment in the study such that dyspareunia pain scores were unable to be assessed.

If sexually active, patients will document self-reported weekly average pelvic pain scores (0 to 10 where 0 is no pain and 10 is worst pain) with sexual intercourse for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Patient will document self-reported daily pain scores via visual analogue scale(0 to 10 where 0 is no pain and 10 is worst pain) for one month prior to starting treatment (1 month),while receiving treatment (3 months)after cessation of treatment(1 month)

Population: Our one patient did not report dyschezia before, during, or after ulipristal treatment.

Patient will document self-reported weekly average pelvic pain scores with defecation (0 to 10 where 0 is no pain and 10 is worst pain) for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.

Outcome measures

Outcome measures
Measure	Ulipristal n=1 Participants 1 patient 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.
Pain With Bowel Movements During treatment	0 units on a scale
Pain With Bowel Movements Prior to treatment	0 units on a scale
Pain With Bowel Movements After treatment	0 units on a scale

Adverse Events

Ulipristal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Serdar Bulun

Northwestern University

Phone: 312-472-3980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place