CompletedPhase 2

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

United States76 participantsStarted 2019-01-15

Plain-language 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.

Who can participate

Age range

18 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 surg…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)

Timeframe: Baseline to Week 16

Trial details

NCT IDNCT03840993

SponsorTanabe Pharma America, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-13

Results submitted2024-04-25

View on ClinicalTrials.gov More Endometrial Related Pain trials