What side effects are associated with this type of intervention?

Common treatments for endometriosis include hormonal therapies such as combined estrogen-progestin contraceptives, progestins, and GnRH agonists. Side effects of these treatments can include bone loss, hot flashes, decreased libido, depression, and hypoestrogenic symptoms. Specifically, GnRH agonists can lead to significant hypoestrogenic side effects like bone density reduction and menopausal symptoms. Progestins may cause weight gain, mood changes, and bloating. Treatments involving NMDA receptor antagonism, like ketamine, can lead to side effects such as dizziness, nausea, increased blood pressure, and potential cognitive effects. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis, primarily focusing on hormonal therapies. These include combined estrogen-progestin contraceptives, progestin-only therapies, and GnRH agonists and antagonists like elagolix. These treatments work by suppressing ovarian function and reducing endometrial tissue activity. While ketamine, an NMDA receptor antagonist, is being studied for its potential in managing endometriosis-related pain, it is not yet an FDA-approved treatment for this condition. Current approved treatments do not typically involve NMDA receptor antagonism.

What other types of research exist?

Promising novel alternatives to Ketamine for endometriosis treatment include: 1) Mast cell stabilizers like ketotifen, which have shown potential in reducing hyperalgesia and inhibiting endometriotic lesion development in preclinical studies. 2) c-Jun NH2-terminal kinase (JNK) inhibitors such as bentamapimod, which have demonstrated efficacy in reducing induced endometriosis in nonhuman primate studies. These alternatives target different pathways and may offer new therapeutic options for endometriosis patients.

← Back to Search

NMDA Receptor Antagonist

Ketamine for Endometriosis Pain

Phase 1

Recruiting

Led By Kathy Huang, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo robotic endometriosis removal surgery

Adults, aged 18 to 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative day (pod) 83

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing whether a small dose of ketamine can help reduce pain after surgery in women with chronic pelvic pain from endometriosis. Ketamine works by blocking pain signals in the brain. Ketamine is an old anesthetic agent that has been explored for its efficacy in treating various pain conditions, including chronic pain and postoperative pain.

Who is the study for?

This trial is for adult women aged 18-65 with chronic pelvic pain who are scheduled for robotic endometriosis removal surgery. Participants should be medically stable and willing to follow the study procedures throughout its duration.

What is being tested?

The UPKEEP Study tests if a low dose of ketamine (0.6 mg/kg) can better manage postoperative pain compared to a saline placebo in female patients after robotic endometriosis surgery. It's randomized and single-blinded, meaning participants won't know which treatment they receive.

What are the potential side effects?

Ketamine may cause side effects such as feelings of disconnection from reality, changes in perception, nausea, dizziness, mood swings, or blurred vision. The severity varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a robotic surgery to remove endometriosis.

Select...

I am between 18 and 65 years old.

Select...

I have had moderate to severe pelvic pain for more than 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative day (pod) 83

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative day (pod) 83

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day (pod) 83 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pelvic Pain Score on Visual Analogue Scale (VAS)

Secondary study objectives

Change in Opioid Use

Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire

Score on General Anxiety Disorder-7 Screener (GAD-7)

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Low-Dose Ketamine (LDK) Treatment GroupExperimental Treatment1 Intervention

Group II: Control GroupPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

FDA approved

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometriosis primarily involve hormonal therapies and non-hormonal options. Estrogen-progestin contraceptives and progestins like dienogest work by suppressing ovulation and reducing menstrual flow, thereby decreasing the hormonal stimulation of endometrial tissue. GnRH agonists and antagonists reduce estrogen production, leading to a hypoestrogenic state that shrinks endometrial lesions. NSAIDs are used to manage pain by reducing inflammation. NMDA receptor antagonists, such as ketamine, offer a different approach by blocking the NMDA receptors involved in pain transmission, which can be particularly beneficial for managing chronic pelvic pain associated with endometriosis. Understanding these mechanisms helps patients and clinicians choose the most appropriate treatment based on symptom severity and individual response.

State of the art, new treatment strategies, and emerging drugs for non-hormonal treatment of endometriosis: a systematic review of randomized control trials.