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Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 1)

Primary Purpose

Uterine Fibroids, Heavy Menstrual Bleeding

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OBE2109
Placebo to match OBE2109
Placebo to match Add-back
Add-back
Sponsored by
ObsEva SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine Fibroid, Leiomyomata, Heavy Menstrual Bleeding, HMB, Heavy Uterine Bleeding, Menorrhagia, OBE2109 + Add-back

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Premenopausal woman at screening.
  • Body Mass Index ≥ 18 kg/m2.
  • Menstrual cycles ≥ 21 days and ≤ 40 days.
  • Presence of uterine fibroids.
  • Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.

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.
  • History of uterus surgery that would interfere with the study.
  • The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided.
  • Undiagnosed abnormal uterine bleeding.
  • Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.

Sites / Locations

  • Site reference ID 192
  • Site reference ID 169
  • Site reference ID 353
  • Site reference ID 232
  • Site reference ID 242
  • Site reference ID 355
  • Site reference ID 211
  • Site reference ID 184
  • Site reference ID 147
  • Site reference ID 154
  • Site reference ID 185
  • Site reference ID 199
  • Site reference ID 111
  • Site reference ID 166
  • Site reference ID 101
  • Site reference ID 239
  • Site reference ID 112
  • Site reference ID 144
  • Site reference ID 246
  • Site reference ID 234
  • Site reference ID 189
  • Site reference ID 105
  • Site reference ID 231
  • Site reference ID 190
  • Site reference ID 168
  • Site reference ID 233
  • Site reference ID 197
  • Site reference ID 135
  • Site reference ID 146
  • Site reference ID 191
  • Site reference ID 204
  • Site reference ID 117
  • Site reference ID 134
  • Site reference ID 129
  • Site reference ID 137
  • Site reference ID 142
  • Site reference ID 110
  • Site reference ID 106
  • Site reference ID 127
  • Site reference ID 107
  • Site reference ID 124
  • Site reference ID 141
  • Site reference ID 140
  • Site reference ID 207
  • Site reference ID 113
  • Site reference ID 163
  • Site reference ID 158
  • Site reference ID 151
  • Site reference ID 150
  • Site reference ID 359
  • Site reference ID 352
  • Site reference ID 174
  • Site reference ID 182
  • Site reference ID 178
  • Site reference ID 354
  • Site reference ID 176
  • Site reference ID 109
  • Site reference ID 248
  • Site reference ID 226
  • Site reference ID 228
  • Site reference ID 149
  • Site reference ID 126
  • Site reference ID 100
  • Site reference ID 145
  • Site reference ID 214
  • Site reference ID 170
  • Site reference ID 138
  • Site reference ID 236
  • Site reference ID 245
  • Site reference ID 175
  • Site reference ID 188
  • Site reference ID 208
  • Site reference ID 133
  • Site reference ID 104
  • Site reference ID 131
  • Site reference ID 102
  • Site reference ID 187
  • Site reference ID 119
  • Site reference ID 186
  • Site reference ID 164
  • Site reference ID 230
  • Site reference ID 213
  • Site reference ID 116
  • Site reference ID 195
  • Site reference ID 222
  • Site reference ID 165
  • Site reference ID 210
  • Site reference ID 148
  • Site reference ID 351
  • Site reference ID 358
  • Site reference ID 159
  • Site reference ID 235
  • Site reference ID 205
  • Site reference ID 180
  • Site reference ID 238
  • Site reference ID 155
  • Site reference ID 201
  • Site reference ID 247
  • Site reference ID 183
  • Site reference ID 216
  • Site reference ID 200
  • Site reference ID 250
  • Site reference ID 244
  • Site reference ID 115
  • Site reference ID 157
  • Site reference ID 120
  • Site reference ID 219
  • Site reference ID 217
  • Site reference ID 218
  • Site reference ID 172
  • Site reference ID 128
  • Site reference ID 125
  • Site reference ID 103
  • Site reference ID 171
  • Site reference ID 123
  • Site reference ID 237

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

OBE2109 dose 1 (100mg) + Placebo Add-back

OBE2109 dose 1 (100mg) + Add-back

OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back

OBE2109 dose 2 (200mg) + Add-back

Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back

Arm Description

At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.

Outcomes

Primary Outcome Measures

Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24
Assessed using the alkaline hematin method

Secondary Outcome Measures

Time to reduced menstrual blood loss
Assessed using the alkaline hematin method
Amenorrhea
Assessed using the alkaline hematin method
Time to amenorrhea
Number of days of uterine bleeding for the last 28-day interval prior to Week 24
Assessed using the alkaline hematin method
Number of days of uterine bleeding for each 28-day interval
Assessed using the alkaline hematin method

Full Information

First Posted
February 17, 2017
Last Updated
June 1, 2021
Sponsor
ObsEva SA
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1. Study Identification

Unique Protocol Identification Number
NCT03070899
Brief Title
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Acronym
PRIMROSE 1
Official Title
A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
April 14, 2020 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ObsEva SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Detailed Description
The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids. Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Heavy Menstrual Bleeding
Keywords
Uterine Fibroid, Leiomyomata, Heavy Menstrual Bleeding, HMB, Heavy Uterine Bleeding, Menorrhagia, OBE2109 + Add-back

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
526 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OBE2109 dose 1 (100mg) + Placebo Add-back
Arm Type
Experimental
Arm Title
OBE2109 dose 1 (100mg) + Add-back
Arm Type
Experimental
Arm Title
OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
Arm Type
Experimental
Arm Title
OBE2109 dose 2 (200mg) + Add-back
Arm Type
Experimental
Arm Title
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back
Arm Type
Placebo Comparator
Arm Description
At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
Intervention Type
Drug
Intervention Name(s)
OBE2109
Intervention Description
OBE2109 100mg tablets for oral administration once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match OBE2109
Intervention Description
Placebo to match OBE2109 100mg tablets for oral administration once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match Add-back
Intervention Description
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Intervention Type
Drug
Intervention Name(s)
Add-back
Intervention Description
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Primary Outcome Measure Information:
Title
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24
Description
Assessed using the alkaline hematin method
Time Frame
From baseline to Week 24
Secondary Outcome Measure Information:
Title
Time to reduced menstrual blood loss
Description
Assessed using the alkaline hematin method
Time Frame
Up to Week 52
Title
Amenorrhea
Description
Assessed using the alkaline hematin method
Time Frame
Up to Week 52
Title
Time to amenorrhea
Time Frame
Up to Week 52
Title
Number of days of uterine bleeding for the last 28-day interval prior to Week 24
Description
Assessed using the alkaline hematin method
Time Frame
last 28-day interval prior to Week 24
Title
Number of days of uterine bleeding for each 28-day interval
Description
Assessed using the alkaline hematin method
Time Frame
Up to Week 52
Other Pre-specified Outcome Measures:
Title
Bone Mineral Density (BMD)
Description
Assessed by dual-energy X-ray absorptiometry (DXA) scan
Time Frame
From baseline up to Week 76
Title
Endometrial biopsy
Description
Assessed by histology
Time Frame
From baseline up to Week 52
Title
Adverse events
Description
Frequency and severity of Treatment-Emergent Adverse Events
Time Frame
Up to Week 76

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Premenopausal woman at screening. Body Mass Index ≥ 18 kg/m2. Menstrual cycles ≥ 21 days and ≤ 40 days. Presence of uterine fibroids. Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method. 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. History of uterus surgery that would interfere with the study. The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided. Undiagnosed abnormal uterine bleeding. Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ObsEva SA
Organizational Affiliation
Geneva
Official's Role
Study Director
Facility Information:
Facility Name
Site reference ID 192
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Site reference ID 169
City
Dothan
State/Province
Alabama
ZIP/Postal Code
33016
Country
United States
Facility Name
Site reference ID 353
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Site reference ID 232
City
Vestavia Hills
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Site reference ID 242
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Site reference ID 355
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Site reference ID 211
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Site reference ID 184
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Site reference ID 147
City
Escondido
State/Province
California
ZIP/Postal Code
92866
Country
United States
Facility Name
Site reference ID 154
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Site reference ID 185
City
Los Angeles
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Site reference ID 199
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Site reference ID 111
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Site reference ID 166
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Site reference ID 101
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Site reference ID 239
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Site reference ID 112
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Site reference ID 144
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Site reference ID 246
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Site reference ID 234
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Site reference ID 189
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Site reference ID 105
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Site reference ID 231
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33433
Country
United States
Facility Name
Site reference ID 190
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Site reference ID 168
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Site reference ID 233
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Site reference ID 197
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Site reference ID 135
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Site reference ID 146
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Site reference ID 191
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Site reference ID 204
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Site reference ID 117
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site reference ID 134
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Site reference ID 129
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Site reference ID 137
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Site reference ID 142
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Site reference ID 110
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Site reference ID 106
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Site reference ID 127
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Site reference ID 107
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Site reference ID 124
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Site reference ID 141
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Site reference ID 140
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site reference ID 207
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Site reference ID 113
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Site reference ID 163
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Site reference ID 158
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30092
Country
United States
Facility Name
Site reference ID 151
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Facility Name
Site reference ID 150
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Site reference ID 359
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Site reference ID 352
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Site reference ID 174
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Site reference ID 182
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Site reference ID 178
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Site reference ID 354
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Site reference ID 176
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Site reference ID 109
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Site reference ID 248
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Site reference ID 226
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Site reference ID 228
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Site reference ID 149
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Site reference ID 126
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Site reference ID 100
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Site reference ID 145
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Site reference ID 214
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Site reference ID 170
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Site reference ID 138
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Site reference ID 236
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Site reference ID 245
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Site reference ID 175
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Site reference ID 188
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Site reference ID 208
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11764
Country
United States
Facility Name
Site reference ID 133
City
Staten Island
State/Province
New York
ZIP/Postal Code
10306
Country
United States
Facility Name
Site reference ID 104
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Site reference ID 131
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Site reference ID 102
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Site reference ID 187
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Site reference ID 119
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site reference ID 186
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Site reference ID 164
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Site reference ID 230
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Site reference ID 213
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Site reference ID 116
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Site reference ID 195
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Site reference ID 222
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Facility Name
Site reference ID 165
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Site reference ID 210
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Site reference ID 148
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Site reference ID 351
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Site reference ID 358
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Facility Name
Site reference ID 159
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Site reference ID 235
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Site reference ID 205
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Site reference ID 180
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Site reference ID 238
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
Country
United States
Facility Name
Site reference ID 155
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Site reference ID 201
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Site reference ID 247
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Site reference ID 183
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site reference ID 216
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site reference ID 200
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Site reference ID 250
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Site reference ID 244
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Site reference ID 115
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Facility Name
Site reference ID 157
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site reference ID 120
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Site reference ID 219
City
Houston
State/Province
Texas
ZIP/Postal Code
77071
Country
United States
Facility Name
Site reference ID 217
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Site reference ID 218
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Facility Name
Site reference ID 172
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Site reference ID 128
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Site reference ID 125
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Site reference ID 103
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Site reference ID 171
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Site reference ID 123
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Site reference ID 237
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36116480
Citation
Donnez J, Taylor HS, Stewart EA, Bradley L, Marsh E, Archer D, Al-Hendy A, Petraglia F, Watts N, Gotteland JP, Bestel E, Terrill P, Loumaye E, Humberstone A, Garner E. Linzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials. Lancet. 2022 Sep 17;400(10356):896-907. doi: 10.1016/S0140-6736(22)01475-1.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

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