SEVERE PAIN during your period?
And before and after?
It’s time to find out more about your ENDOMETRIOSIS.
Help us study an investigational medication that may reduce endometriosis pain.
The INANNA study is evaluating an investigational medication in women with moderate or severe endometriosis pain.
You may qualify to participate if you:
- Are between 18 and 49 years of age
Have been diagnosed with endometriosis by surgery within the last 10 years and be able to provide documentation of the surgery
- Have a 21-38 day menstrual cycle
- Are not pregnant, nursing or planning a pregnancy within the next 12 months
- Are willing to stop taking current hormonal endometriosis therapies (use of nonhormonal contraception methods is required during the study)
Other criteria will be reviewed to determine if you qualify for this study.
Physicians’ Research Options (PRO) is an experienced Clinical Research Company dedicated to the performance of Phase II, III and IV Pharmaceutical and Pilot/Pivotal Medical Device clinical trials. Our staff experience totals over 60 years in Clinical / Medical Research.
Our staff recruits for and manages studies in Utah, Nevada, and Colorado.
What is Endometriosis?
Endometriosis is an often painful disorder in which tissue that normally lines the inside of your uterus–the endometrium–grows outside of your uterus. Endometriosis most commonly involves your ovaries, fallopian tubes, and the tissue lining your pelvis.
What is the Purpose of the INANNA Study?
This study is testing whether an investigational medication called MT-2990 could reduce pain associated with endometriosis. MT-2990 is different from other medications that are commonly used to treat endometriosis. It is designed to specifically target cells in the body’s immune system that cause inflammation associated with endometriosis pain. This study will help measure how effective and safe it might be in reducing that pain.
What is Involved in the INANNA Study?
Participation in the study will last about 1 year and will require approximately 9 visits to the research clinic and 2 scheduled follow-up phone calls.
The study is divided into several phases:
- Washout Period (around 2-3 months): Women who are using hormonal therapies will need to stop using these and will need to start using study-approved methods of birth control. You may also need to stop using certain pain-relieving medications and switch to study-approved options.
- Screening Period (around 2-3 months): Tests and assessments will be performed to determine whether you meet the criteria to participate in the study. In addition, you will need to have two menstrual cycles that are 21-38 days long during the Screening Period to be eligible to participate in the study.
- Study Treatment Period (around 4 months): You will be randomly assigned (like the flip of a coin) to study treatment with either the investigational drug or placebo (an inactive substance). You will receive the study treatment through IV infusion once each month and attend 4 other visits for tests and to check on your health.
- Follow-Up Period (around 5 months): You will receive 2 planned phone calls over this time to check up on your overall health, endometriosis-related pain, use of medications and whether you have had any hospital admissions or endometriosis-related surgeries.
Will the Study Cost Anything?
The study medication, clinic visits, laboratory tests, and procedures that are part of the study will be provided at no cost. You and/or your usual health care payer will be responsible for any other health care costs unrelated to the study. You may also be compensated for your time and study-related travel expenses. The study staff will provide more information about any possible compensation.