Phase
Condition
Endometriosis
Treatment
HMI-115
Placebo
Clinical Study ID
Ages 18-49 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at thetime of signing informed consent.
Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy)as documented by medical records within 10 years before screening.
Subject must have a Composite Pelvic Signs and Symptoms Score total score of ≥ 6with a score of at least 2 for DYS and at least 2 for NMPP at screening.
Subject agrees not to participate in another interventional study whileparticipating in the present study.
Exclusion
Exclusion Criteria:
Subject is pregnant or breastfeeding or is planning a pregnancy during the studyperiod.
Subject has chronic pelvic pain that is not caused by endometriosis or has any otherchronic pain syndrome or other chronic therapy, or that would interfere with theassessment of endometriosis-related pain
Subject has clinically significant gynecologic condition other than endometriosis
Subject has previous history of a severe, life-threatening or other significantsensitivity to any opioids or non-steroidal anti inflammatory drugs (NSAIDS) or anycontraindication to their use such as gastrointestinal ulcer or bleeding
Subject has history of hysterectomy and/or bilateral oophorectomy
Subjects with past or present pituitary tumor growth
Subjects has a history of osteoporosis or other metabolic bone disease
Study Design
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing 100703
ChinaActive - Recruiting
HopeMed HopeMed
Nanjing, Utah 84020-7163
ChinaSite Not Available
Instytut Matki i Dziecka
Warszawa, Mazowieckie
PolandCompleted
Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego
Bialystok, Podlaskie
PolandCompleted
Gtc Research
Shawnee Mission, Kansas 66218
United StatesSite Not Available
Complete Healthcare For Woman
Columbus, Ohio 43231
United StatesSite Not Available
Cedar Health Research
Dallas, Texas 75251
United StatesSite Not Available
The Woman's Hospital of Texas Clinical Research Center
Houston, Texas 77024
United StatesSite Not Available
Complete Healthcare For Woman
Kingwood, Texas 77339-1510
United StatesSite Not Available
Physicians' Research Options, LLC- Corner Canyon Clinic
Draper, Utah 84020
United StatesCompleted
Tidewater Clinical Research/TPW
Norfolk, Virginia 23502
United StatesCompleted
Seattle Women's: Health, Research, Gynecology
Seattle, Washington 98105
United StatesSite Not Available
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