Endometriosis
Conditions
Keywords
Endometriosis, chronic pelvic pain, dysmenorrhea, dyschezia, bleeding, ulipristal, progesterone
Brief 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.
Detailed description
This study will assess the use of a medication to improve symptoms of chronic, endometriosis-related pelvic pain among women who did no achieve relief with prior surgical and medical treatments.
Interventions
DRUGUlipristal
Patient will take 15mg every other day, or every 4 days per week.
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of endometriosis with surgical confirmation via laparoscopy performed within 3 years prior to study enrollment * English-speaking reproductive-age women (18-50yo) with regular, cyclical menses * Treatment-refractory endometriosis, as defined by persistent or recurrent pelvic pain following one or more treatments involving surgery and/or hormonal treatment * Dysmenorrhea and chronic pelvic pain for a least one week out of the month during past 5 months or longer * Endometrial biopsy before and after intervention * Adequate organ and marrow function as defined below: * leukocytes ≥ 3,000/microliter * absolute neutrophil count ≥ 1,500/microliter * platelets ≥ 100,000/microliter * total bilirubin within normal institutional limits * Liver function tests ≤ 2.5 X institutional upper limit of normal * creatinine within normal institutional limits * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
* Undiagnosed vaginal bleeding * Abnormal results from endometrial biopsy * Presence of ovarian cysts ≥ 3 cm * Pregnancy * Refusal to adhere the birth control strategy of the study (use of a combination of a condom and a vaginal sponge during each intercourse while on ulipristal, plus one month before the onset and one month after the completion of ulipristal therapy) * Women taking digoxin, dabigatran or etexilate due to interference of ulipristal acetate with the concentration of these substances bound by plasma proteins. * Women taking moderate to potent inducers of hepatic metabolism (e.g. erythromycin, ketoconazole, ritonavir, nefazodone). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ulipristal. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active pulmonary, cardiac, renal, hepatic or thromboembolic disease, infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Pain | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Bleeding | 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). |
| Pain With Sexual Intercourse | 5 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain With Bowel Movements | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ulipristal 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Ulipristal |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 25 years |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Pelvic Pain
Scores were collected daily and averaged together for each period
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ulipristal | Pelvic Pain | Prior to starting therapy | 3.5 units on a scale | Standard Error 0.57 |
| Ulipristal | Pelvic Pain | During therapy | 0.2 units on a scale | Standard Error 0.06 |
| Ulipristal | Pelvic Pain | After cessation of therapy | 3.9 units on a scale | Standard Error 0.43 |
p-value: <0.05Wilcoxon signed rank
Secondary
Pain With Sexual Intercourse
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.
Time frame: 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.
Secondary
Vaginal Bleeding
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).
Time frame: 5 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulipristal | Vaginal Bleeding | Prior to therapy | 3 pads or tampons |
| Ulipristal | Vaginal Bleeding | During therapy | 0 pads or tampons |
| Ulipristal | Vaginal Bleeding | After cessation of therapy | 3 pads or tampons |
Other Pre-specified
Pain With Bowel Movements
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulipristal | Pain With Bowel Movements | Prior to treatment | 0 units on a scale |
| Ulipristal | Pain With Bowel Movements | During treatment | 0 units on a scale |
| Ulipristal | Pain With Bowel Movements | After treatment | 0 units on a scale |