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Completed

NCT Number: NCT03840993

Safety and Efficacy Study of MT-2990 in Women With Endometriosis

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.

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Key information

Conditions

Endometrial Related Pain Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Precision Trials, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

MT-2990

Drug

over 16 weeks

Placebo

Drug

over 16 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used

    Time frame: Baseline to Week 16

  7. Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used

    Time frame: Baseline to Week 16

  8. Time to Use of Rescue Medication (Analgesic)

    Time frame: Baseline to Week 16

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  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

  17. 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

  18. 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

  19. 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

  20. 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

  21. Number of Responders Using Global 7-point Scale

    Time frame: Baseline to Week 16

  22. Percentage of Responders Using Global 7-point Scale

    Time frame: Baseline to Week 16

  23. 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

  24. Number of Responders Using Endometriosis Specific 7-point Scale

    Time frame: Baseline to Week 16

  25. Percentage of Responders Using Endometriosis Specific 7-point Scale

    Time frame: Baseline to Week 16

  26. 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

  27. 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

  28. 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

  29. 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

Sponsors and collaborators

Lead sponsor

Tanabe Pharma America, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2019
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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