Endometrial Related PainPhase 2NCT03840993
Safety and Efficacy Study of MT-2990 in Women With Endometriosis
A Phase 2 study testing MT-2990 in people with Endometrial Related Pain, run by Tanabe Pharma America, Inc. at 51 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of moderate to severe endometriosis-related pain in women with surgically diagnosed endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometrial Related Pain
- What is being tested?
- MT-2990
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 51 sitesUnited States
- Study dates
- 15 Jan 2019to 5 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Provide written informed consent to participate in this study
- Agree to approximately 30-90 day washout interval of hormonal therapies, if applicable
- Have a history of regular menstrual cycles
- Have a body mass index < 45 kg/m^2 (inclusive)
- Have documented surgical/laparoscopy diagnosis of endometriosis with 10 years
- Agree to use 2 forms of nonhormonal contraception throughout the study
- In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements including transvaginal ultrasound.
- Have moderate to severe endometrial related pain
Who cannot join
- Subject is pregnant, breast feeding, or planning a pregnancy.
- Subject is < 6 months postpartum, postabortion, or post-pregnancy.
- Willing to remove a hormonal intrauterine device (IUD) at least 30 days prior to screening. (Non hormonal IUDs do not have to be removed)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) , or total bilirubin ≥ 2.0 × upper limit of normal (ULN) above the reference range
- Have immunosuppression due to underlying medical condition
- Corrected QT interval using Fridericia's formula (QTcF) or Corrected QT interval using Bazett's formula (QTcB) ≥ 450 msec or clinically important abnormal findings on the ECG
Show all 13Show fewer
- Subject is not up-to-date on breast screening according to current guidelines.
- Has a surgical history of hysterectomy, bilateral oophorectomy and any other recent major surgery
- Subject is required more than 2 weeks of continuous use of prohibited long-acting narcotic or immediate release narcotic for treatment of endometriosis-associated pain.
- Have chronic pelvic pain for nonendometriosis related causes, which require systemic pharmaceutical chronic therapy for pain
- Have other chronic pain syndrome which require chronic analgesic or other chronic therapy
- Have a clinically significant gynecologic condition identified on the transvaginal ultrasound (TVU) (e.g., complex ovarian cyst > 3 cm or simple ovarian cyst > 5 cm, clinically significant endometrial pathology, single fibroid ≥ 4 cm or multiple (> 4) fibroids that measure ≥ 2 cm or symptomatic submucosal fibroid of any size
- Have a current history of undiagnosed abnormal genital bleeding
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Agile Clinical Research Trials
Alpharetta, Georgia, 30005
Medi-Sense
Atlanta, Georgia, 30363
Northwest Clinical Research Center
Bellevue, Washington, 98007
Wake Research Associates
Chattanooga, Tennessee, 37421
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Aventive Research - Colombus
Columbus, Ohio, 43213
Clinical Trials Management - Covington Northshore Office
Covington, Louisiana, 70433
Physician's Research Options (PRO)
Draper, Utah, 84020
NuDirections Clinical Research
Dunwoody, Georgia, 30338
Carolina Women's Research and Wellness Clinic
Durham, North Carolina, 27713
Clinical Physiology Associates - Fort Myers
Fort Myers, Florida, 33912
AGA Clinical Trials
Hialeah, Florida, 33012
Kendall South Medical Center
Hialeah, Florida, 33012
South Florida Clinical Trials
Hialeah, Florida, 33016
Precision Research Institute - Houston
Houston, Texas, 77036
Clinical Trial Network
Houston, Texas, 77074
Biopharma Informatic - Houston
Houston, Texas, 77084
Clinical Research Prime
Idaho Falls, Idaho, 83404
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
Altus Research
Lake Worth, Florida, 33461
Axcess Medical Research
Loxahatchee Groves, Florida, 33470
Drug Studies America - Marietta
Marietta, Georgia, 30060
Advanced Clinical Research - Idaho
Meridian, Idaho, 83642
Southern Clinical Research Associates
Metairie, Louisiana, 70001
Health and Life Research Institute
Miami, Florida, 33155
Ivetmar Medical Group
Miami, Florida, 33155
Future Care Solution
Miami, Florida, 33165
Advanced Medical Research Institute
Miami, Florida, 33174
South Florida Research Phase I-IV
Miami Springs, Florida, 33166
North Star Medical Research
Middleburg Heights, Ohio, 44130
Manhattan Medical Research
New York, New York, 10016
Health Research of Hampton Roads
Newport News, Virginia, 23606
The Advanced Gynecologic Surgery Institute
Park Ridge, Illinois, 60068
American Research Centers of Florida
Pembroke Pines, Florida, 33027
Precision Trials
Phoenix, Arizona, 85032
Physician's Research Options (PRO)
Pleasant Grove, Utah, 84062
Unified Women's Clinical Research - Raleigh
Raleigh, North Carolina, 27607
PMG Research of Rocky Mount
Rocky Mount, North Carolina, 27804
Northern California Research Corporation
Sacramento, California, 95821
Saginaw Valley Medical Research Group/Women's OB-GYN
Saginaw, Michigan, 48604
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Discovery Clinical Trials
San Antonio, Texas, 78258
Ageless and Beautiful Medical Spa
San Diego, California, 92103
Precision Research Institute
San Diego, California, 92114
GTC Research
Shawnee Mission, Kansas, 66218
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118
ClinEdge - Fusion Clinical Research of Spartanburg
Spartanburg, South Carolina, 29301
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
Continental Clinical Solutions
Towson, Maryland, 21204
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of MT-2990 in Women With Endometriosis Experiencing Endometrial Related Pain
The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of moderate to severe endometriosis-related pain in women with surgically diagnosed endometriosis.
- Conditions
- Endometrial Related Pain
- Being tested
- MT-2990, Placebo
- Keywords
- Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-2990Drug
over 16 weeks
PlaceboDrug
over 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| MT-2990 | Experimental | MT-2990, over 16 weeks Receives: Drug: MT-2990 |
| Placebo | Placebo comparator | Placebo, over 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
Measured: Baseline to Week 16
Secondary outcomes (29)
Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
Measured: Baseline to Week 16
Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
Measured: Baseline to Week 16
Mean Change From Baseline to Week 16 in Non-Menstrual Pelvic Pain (NMPP) Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)
Measured: Baseline to Week 16
Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)
Measured: Baseline to Week 16
Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain)
Measured: Baseline to Week 16
Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used
Measured: Baseline to Week 16
Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used
Measured: Baseline to Week 16
Time to Use of Rescue Medication (Analgesic)
Measured: Baseline to Week 16
Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Measured: Baseline to Week 16
Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Measured: Baseline to Week 16
Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe)
Measured: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Measured: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Measured: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Measured: Baseline to Week 16
Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Measured: Baseline to Week 16
Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Measured: Baseline to Week 16
Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Measured: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Measured: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Measured: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Measured: Baseline to Week 16
Number of Responders Using Global 7-point Scale
Measured: Baseline to Week 16
Percentage of Responders Using Global 7-point Scale
Measured: Baseline to Week 16
Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Measured: From Baseline to Weeks 4, 8, 12, and 16
Number of Responders Using Endometriosis Specific 7-point Scale
Measured: Baseline to Week 16
Percentage of Responders Using Endometriosis Specific 7-point Scale
Measured: Baseline to Week 16
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Measured: From Baseline to Weeks 4, 8, 12, and 16
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Measured: From Baseline to Weeks 4, 8, 12, and 16
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Measured: From Baseline to Weeks 4, 8, 12, and 16
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Measured: From Baseline to Weeks 4, 8, 12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start15 Jan 2019
- Primary completion13 May 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial Related PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Medical Science, Study director, Tanabe Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840993
- Sponsor's protocol ID
- MT-2990-A01
- Status last verified
- Dec 2025
- First submitted
- 4 Feb 2019
- Last updated
- 31 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of MT-2990 in Women With Endometriosis Experiencing Endometrial Related Pain
- ClinicalTrials.gov ID
- NCT03840993
- Acronym / sponsor ID
- MT-2990-A01
- Conditions
- Endometrial Related Pain
- Keywords
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Tanabe Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of moderate to severe endometriosis-related pain in women with surgically diagnosed endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT-2990 | Experimental | Drug: MT-2990MT-2990, over 16 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, over 16 weeks |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provide written informed consent to participate in this study
- Agree to approximately 30-90 day washout interval of hormonal therapies, if applicable
- Have a history of regular menstrual cycles
- Have a body mass index < 45 kg/m^2 (inclusive)
- Have documented surgical/laparoscopy diagnosis of endometriosis with 10 years
Key exclusion criteria (13 listed)
- Subject is pregnant, breast feeding, or planning a pregnancy.
- Subject is < 6 months postpartum, postabortion, or post-pregnancy.
- Willing to remove a hormonal intrauterine device (IUD) at least 30 days prior to screening. (Non hormonal IUDs do not have to be removed)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) , or total bilirubin ≥ 2.0 × upper limit of normal (ULN) above the reference range
- Have immunosuppression due to underlying medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-2990over 16 weeks | Drug | MT-2990 |
| Placeboover 16 weeks | Drug | Placebo |
Primary outcome
Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
Time frame: Baseline to Week 16
29 secondary outcomes
Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
Time frame: Baseline to Week 16
Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
Time frame: Baseline to Week 16
Mean Change From Baseline to Week 16 in Non-Menstrual Pelvic Pain (NMPP) Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)
Time frame: Baseline to Week 16
Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)
Time frame: Baseline to Week 16
Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain)
Time frame: Baseline to Week 16
Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used
Time frame: Baseline to Week 16
Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used
Time frame: Baseline to Week 16
Time to Use of Rescue Medication (Analgesic)
Time frame: Baseline to Week 16
Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Time frame: Baseline to Week 16
Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Time frame: Baseline to Week 16
Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe)
Time frame: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Time frame: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Time frame: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Time frame: Baseline to Week 16
Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Time frame: Baseline to Week 16
Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Time frame: Baseline to Week 16
Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Time frame: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Time frame: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Time frame: Baseline to Week 16
Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
Time frame: Baseline to Week 16
Number of Responders Using Global 7-point Scale
Time frame: Baseline to Week 16
Percentage of Responders Using Global 7-point Scale
Time frame: Baseline to Week 16
Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Number of Responders Using Endometriosis Specific 7-point Scale
Time frame: Baseline to Week 16
Percentage of Responders Using Endometriosis Specific 7-point Scale
Time frame: Baseline to Week 16
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Head of Medical Science study director
Tanabe Pharma America, Inc.
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-2990 in people with Endometrial Related Pain, run by Tanabe Pharma America, Inc. at 51 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe) (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.