A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis



Status:Active, not recruiting
Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 45
Updated:7/26/2018
Start Date:July 2016
End Date:July 2019

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A Randomized, Double-blind, Placebo-controlled, Phase 2b Dose-ranging Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis Associated Pain

The primary objective of this study is to assess the efficacy and safety of a range of oral
doses of OBE2109 versus placebo, in reducing endometriosis associated pain.

The study is a prospective, dose-finding, randomized, parallel group, double-blind,
placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the
treatment of 330 women with moderate-to-severe endometriosis associated pain.

Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo
group, 5 dose groups with different dosage/regimen).

Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an
extension phase. Subjects who do not continue in the extension will enter the treatment-free
follow-up phase of the study.

Key Inclusion Criteria:

- The subject must have had her most recent surgical and - if available - histological,
diagnosis of pelvic endometriosis up to 10 years before screening.

- The subject has moderate to severe endometriosis-associated pain during the screening
period.

- The subject has regular menstrual cycles.

- The subject has a BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

- The subject is pregnant or breast feeding or is planning a pregnancy within the
duration of the treatment period of the study.

- The subject had an interventional surgery for endometriosis performed within a period
of 60 days before screening.

- The subject did not respond to prior treatment with gonadotropin releasing hormone
(GnRH) agonists or GnRH antagonists for endometriosis.

- The subject has a history of, or known osteoporosis or other metabolic bone disease.

- The subject has chronic pelvic pain that is not caused by endometriosis and requires
chronic analgesic / therapy, or that would interfere with the assessment of
endometriosis related pain.
We found this trial at
63
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1963
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Tiffin, OH
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1184
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Albuquerque, NM
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Ann Arbor, MI
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Arcadia, CA
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2178
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Atlanta, GA
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1775
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Austin, TX
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Bay City, MI
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Beaumont, TX
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2708
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Boca Raton, FL
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2168
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Bristol, TN
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2133
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Bryn Mawr, PA
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Centreville, VA
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1128
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Chandler, AZ
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2083
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Chattanooga, TN
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971
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Chino, CA
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2512
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Clearwater, FL
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2321
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Columbia, SC
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1682
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Dallas, TX
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1961
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Dayton, OH
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1020
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Denver, CO
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714
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from 98109
Draper, UT
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Fall River, Massachusetts 02720
2502
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Fall River, MA
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1660
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from 98109
Fort Worth, TX
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420 West 12th Avenue
Franklin, Ohio 43210
2006
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from 98109
Franklin, OH
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2450
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Gainesville, FL
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2332
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Glen Burnie, MD
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Greensboro, North Carolina 27401
2298
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from 98109
Greensboro, NC
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1890
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Houston, TX
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Huntington Park, California 90255
967
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Huntington Park, CA
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2371
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Jenkintown, PA
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2659
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Jensen Beach, FL
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5292
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Katowice,
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1018
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Lakewood, CO
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997
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Longmont, CO
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2100
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Marrero, LA
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2091
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Metairie, LA
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Miami, FL
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Miami Lakes, FL
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2725
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Miami Springs, FL
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Morehead City, North Carolina 28557
2490
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Morehead City, NC
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395
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Nampa, ID
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1970
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Nashville, TN
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2501
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New Port Richey, FL
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2400
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New York, NY
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Norfolk, VA
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Northridge, California
946
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Northridge, CA
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1719
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Oak Brook, IL
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2348
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Richmond, VA
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Saginaw, MI
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San Antonio, TX
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San Diego, CA
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Schertz, TX
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Scottsdale, AZ
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2
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Seattle, WA
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Shawnee Mission, KS
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1921
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Southfield, MI
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2527
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Tampa, FL
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988
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Tustin, CA
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Washington,
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1911
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Webster, TX
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2686
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from 98109
Wellington, FL
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2006
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from 98109
Westerville, OH
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1435
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from 98109
Wichita, KS
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