Endometriosis
Conditions
Keywords
Peroxisome Proliferator-Activated Receptors, treatment of endometriosis
Brief summary
The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in reducing pelvic pain in early stage endometriosis patients.
Detailed description
There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. Women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial. Comparison: Following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. Efficacy comparisons will be made utilizing visual analog scale diaries, Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36. Secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.
Interventions
DRUGRosiglitazone
Sponsors
Berlex Foundation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Healthy women ages 18 - 45 years. * Regular menstrual cycles (24-35 days). * Pelvic pain ≥ 3 months with cyclical component. * Negative pregnancy test and must use nonhormonal contraception. * Non-lactating. * No history of liver disease. * Consent to participate in the study. * Endometriosis diagnosed from surgical specimen by routine hematoxylin and eosin staining and histological evaluation within the past 4 years.
Exclusion criteria
* Major psychiatric conditions or the abuse of alcohol or drugs which would make it difficult for the subject to complete study procedures. * Active or prior infection with hepatitis, human immunodeficiency virus (HIV) infection, or history of high-risk activities (e.g., IV drug abuse) which would increase risk to laboratory personnel. Of note, no testing for hepatitis or HIV will be performed as part of this study and all tissues will be handled and discarded as if they were potentially infected. * Patients with liver dysfunction (elevated liver enzymes \> 2 times the upper limit of normal). * Presence of pre-existing malignancy, including carcinoma of the breast or uterus. * Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric. * Elevated WBC. * NYHA functional class I-IV heart failure. * Diabetics. * Known pregnancy or positive pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Short-Form McGill Pain Questionnaire at study entry and at 3 and 6 months | — |
| Physical component summary score of the SF-36 at baseline and at 3 and 6 months | — |
| Cytokine quantification | — |
| Proteomics | — |
| Gene array analyses | — |
Countries
United States
Outcome results
None listed