Endometriosis Clinical Trial
Official title:
Novel, Non-Hormonal Therapy for the Treatment of Chronic Pain Due to Endometriosis in Adolescent and Adult Women
Endometriosis is dependent on angiogenesis (the sprouting of new blood vessels) for its growth and maintenance, but the side effects of currently approved angiogenesis inhibitors make these agents inappropriate for use in reproductive-age patients. This obstacle will be overcome by performing a randomized, double blind clinical trial aimed at repurposing an existing drug, cabergoline, as a safe, alternative angiogenesis inhibitor for adolescents and young women with endometriosis. This trial proposes a novel, non-hormonal, non-surgical therapeutic approach aimed at alleviating the pain and suffering associated with this common chronic disease that currently has limited treatment options.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years to 40 Years |
Eligibility | Inclusion Criteria: - Female with surgically-confirmed endometriosis - Age 15 years to 40 years - Current use = 2 months duration of hormonal therapy such as combined oral contraceptives, norethindrone acetate, or levonorgestrel intrauterine device - Current pelvic pain (score = 3 on Visual Analog Scale, where 0 represents absence of pain and 10 indicates unbearable pain) present for = 14 days/month over the 2 months prior to study enrollment - Willingness to comply with visit schedule and protocol Exclusion Criteria: - Pre-menarche or post-menopause - Contraindications to cabergoline (e.g., cardiac valve disorder; pulmonary, pericardial, retroperitoneal fibrotic disorder; hypersensitivity to ergot derivatives; uncontrolled hypertension) - Significant mental or chronic systemic illness that might confound pain assessment or the ability to complete the study - Pregnant, breastfeeding, or planning to become pregnant in the next 6 months - Impaired liver function (ALT > 2x normal) or liver disease - Breast cancer, current or previous - Thromboembolic disease, current or previous - Use of other drugs that affect dopamine (e.g., phenothiazines, metoclopramide, butyrophenones) |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Children's Hospital Boston | Boston | Massachusetts |
United States | Standford University | Palo Alto | California |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Stanford University, Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 months | BPI: A 7-item self-report measure. The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assesses the extent to which pain interferes with sleep. Either the item asking about the "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference. The BPI is anchored between a scale of zero (no pain/interference) to ten (maximum pain/interference). The magnitude of treatment-associated change in BPI Interference Scale scores in open-label and randomized clinical trials ranges from 1 to 3 points, depending on the specific pain conditions and treatments studied. | every 6 weeks for 6 months | |
Primary | Change in pain severity measured by Visual Analog Scale (VAS) over 6 months | VAS: A measurement of pain intensity, assessed by a 0 to 10 numerical rating scale, to rate maximum and average pain intensity over the preceding 7 days. Higher scores indicate more severe pain intensity. | every 6 weeks for 6 months | |
Primary | Change in pain measured by Biberoglu and Behrman patient ratings scale (B&B pain scale) over 6 months | Biberoglu and Behrman patient ratings scale (B&B pain scale): Survey that assesses dyspareunia, dysmenorrhea, and noncyclic pelvic pain. Each is graded on a scale from 0 to 3 (or 4), with higher numbers indicating more severe symptoms. | every 6 weeks for 6 months | |
Secondary | Change in measurements of serum biomarkers of angiogenesis and inflammation over 6 months | Measurement of serum concentrations of high sensitivity C-reactive protein, interleukins 1B and 8, tumor necrosis factor alpha, and vascular endothelial growth factor | every 3 months for 6 months | |
Secondary | Change in cardiovascular dysfunction measured by pulse wave velocity over 6 months | Peripheral wave velocity is an ultrasound measurement of the rate at which pressure waves move down a blood vessel. It is collected by using two pressure catheters placed a known distance from one another, the "Pulse Wave Distance". | baseline and 6 months | |
Secondary | Change in measures of central hypersensitization measured by quantitative sensory testing at 6 months | Quantitative sensory testing (QST) is a single, standardized protocolized test that involves measurement of 3 pain threshold tests (cutaneous dynamic brush allodynia, muscular pain threshold, temporal summation test) that will be measured at the abdomen | every 3 months for 6 months | |
Secondary | Incidence of vaginal bleeding over 6 months | Measurement of the incidence of vaginal bleeding using phone-based survey to document the presence/absence of vaginal bleeding | completed daily for 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01931670 -
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Recruiting |
NCT05648669 -
A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Completed |
NCT04081532 -
The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain
|
N/A | |
Recruiting |
NCT06101303 -
Endometriosis Pain
|
||
Completed |
NCT04665414 -
Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
|
||
Completed |
NCT03690765 -
Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
|
||
Recruiting |
NCT05153512 -
ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
|
||
Active, not recruiting |
NCT04171297 -
Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
|
||
Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
Completed |
NCT04565470 -
Strategies of Self-management of Endometriosis Symptoms
|
||
Completed |
NCT03613298 -
Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.
|
N/A | |
Withdrawn |
NCT05568940 -
Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
|
||
Not yet recruiting |
NCT03464799 -
Does Immunotherapy Have a Role in the Management of Endometriosis?
|
||
Active, not recruiting |
NCT03002870 -
Characteristics of Patient Population With Endometriosis
|
N/A | |
Completed |
NCT02973854 -
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
|
||
Withdrawn |
NCT03272360 -
Endometriosis Biomarker Discovery Study
|
N/A | |
Recruiting |
NCT02481739 -
Laparoscopic Surgical Management of Endometriosis on Fertility
|
N/A | |
Active, not recruiting |
NCT02754648 -
Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve
|
N/A | |
Completed |
NCT06106932 -
GnRH-a on Angiogenesis of Endometriosis
|
N/A | |
Completed |
NCT02387931 -
Supplementation in Adolescent Girls With Endometriosis
|
Phase 4 |