PRIMROSE 1: Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Sponsor
ObsEva SA (Industry)
Overall Status
Completed
CT.gov ID
NCT03070899
Collaborator
(none)
526
116
5
47.7
4.5
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
526 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Apr 20, 2017
Actual Primary Completion Date
:
Apr 14, 2020
Actual Study Completion Date
:
Apr 12, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OBE2109 dose 1 (100mg) + Placebo Add-back
|
Drug: OBE2109
OBE2109 100mg tablets for oral administration once daily
Drug: Placebo to match OBE2109
Placebo to match OBE2109 100mg tablets for oral administration once daily
Drug: Placebo to match Add-back
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
|
| Experimental: OBE2109 dose 1 (100mg) + Add-back
|
Drug: OBE2109
OBE2109 100mg tablets for oral administration once daily
Drug: Placebo to match OBE2109
Placebo to match OBE2109 100mg tablets for oral administration once daily
Drug: Add-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
|
| Experimental: OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back
|
Drug: OBE2109
OBE2109 100mg tablets for oral administration once daily
Drug: Placebo to match Add-back
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Drug: Add-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
|
| Experimental: OBE2109 dose 2 (200mg) + Add-back
|
Drug: OBE2109
OBE2109 100mg tablets for oral administration once daily
Drug: Add-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
|
| Placebo Comparator: Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization. |
Drug: OBE2109
OBE2109 100mg tablets for oral administration once daily
Drug: Placebo to match OBE2109
Placebo to match OBE2109 100mg tablets for oral administration once daily
Drug: Placebo to match Add-back
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Drug: Add-back
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
|
Outcome Measures
Primary Outcome Measures
- Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24 [From baseline to Week 24]
Assessed using the alkaline hematin method
Secondary Outcome Measures
- Time to reduced menstrual blood loss [Up to Week 52]
Assessed using the alkaline hematin method
- Amenorrhea [Up to Week 52]
Assessed using the alkaline hematin method
- Time to amenorrhea [Up to Week 52]
- Number of days of uterine bleeding for the last 28-day interval prior to Week 24 [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 [Up to Week 52]
Assessed using the alkaline hematin method
Other Outcome Measures
- Bone Mineral Density (BMD) [From baseline up to Week 76]
Assessed by dual-energy X-ray absorptiometry (DXA) scan
- Endometrial biopsy [From baseline up to Week 52]
Assessed by histology
- Adverse events [Up to Week 76]
Frequency and severity of Treatment-Emergent Adverse Events
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site reference ID 192 | Birmingham | Alabama | United States | 35205 |
| 2 | Site reference ID 169 | Dothan | Alabama | United States | 33016 |
| 3 | Site reference ID 353 | Mobile | Alabama | United States | 36608 |
| 4 | Site reference ID 232 | Vestavia Hills | Alabama | United States | 35216 |
| 5 | Site reference ID 242 | Phoenix | Arizona | United States | 85015 |
| 6 | Site reference ID 355 | Tucson | Arizona | United States | 85712 |
| 7 | Site reference ID 211 | Arcadia | California | United States | 91007 |
| 8 | Site reference ID 184 | Cerritos | California | United States | 90703 |
| 9 | Site reference ID 147 | Escondido | California | United States | 92866 |
| 10 | Site reference ID 154 | Huntington Park | California | United States | 90255 |
| 11 | Site reference ID 185 | Los Angeles | California | United States | 90255 |
| 12 | Site reference ID 199 | Northridge | California | United States | 91324 |
| 13 | Site reference ID 111 | Panorama City | California | United States | 91402 |
| 14 | Site reference ID 166 | Sacramento | California | United States | 95821 |
| 15 | Site reference ID 101 | San Diego | California | United States | 92108 |
| 16 | Site reference ID 239 | Upland | California | United States | 91786 |
| 17 | Site reference ID 112 | Westminster | California | United States | 92683 |
| 18 | Site reference ID 144 | Denver | Colorado | United States | 80246 |
| 19 | Site reference ID 246 | Englewood | Colorado | United States | 80112 |
| 20 | Site reference ID 234 | Thornton | Colorado | United States | 80229 |
| 21 | Site reference ID 189 | New Haven | Connecticut | United States | 06519 |
| 22 | Site reference ID 105 | Washington | District of Columbia | United States | 20036 |
| 23 | Site reference ID 231 | Boca Raton | Florida | United States | 33433 |
| 24 | Site reference ID 190 | Boca Raton | Florida | United States | 33486 |
| 25 | Site reference ID 168 | Clearwater | Florida | United States | 33759 |
| 26 | Site reference ID 233 | DeLand | Florida | United States | 32720 |
| 27 | Site reference ID 197 | Fort Lauderdale | Florida | United States | 33316 |
| 28 | Site reference ID 135 | Hialeah | Florida | United States | 33012 |
| 29 | Site reference ID 146 | Hialeah | Florida | United States | 33012 |
| 30 | Site reference ID 191 | Jacksonville | Florida | United States | 32256 |
| 31 | Site reference ID 204 | Loxahatchee Groves | Florida | United States | 33470 |
| 32 | Site reference ID 117 | Miami Lakes | Florida | United States | 33016 |
| 33 | Site reference ID 134 | Miami Lakes | Florida | United States | 33016 |
| 34 | Site reference ID 129 | Miami Springs | Florida | United States | 33166 |
| 35 | Site reference ID 137 | Miami | Florida | United States | 33130 |
| 36 | Site reference ID 142 | Miami | Florida | United States | 33144 |
| 37 | Site reference ID 110 | Miami | Florida | United States | 33165 |
| 38 | Site reference ID 106 | Miami | Florida | United States | 33176 |
| 39 | Site reference ID 127 | Miami | Florida | United States | 33176 |
| 40 | Site reference ID 107 | Miramar | Florida | United States | 33027 |
| 41 | Site reference ID 124 | New Port Richey | Florida | United States | 34653 |
| 42 | Site reference ID 141 | Orlando | Florida | United States | 32801 |
| 43 | Site reference ID 140 | Orlando | Florida | United States | 32806 |
| 44 | Site reference ID 207 | Saint Petersburg | Florida | United States | 33709 |
| 45 | Site reference ID 113 | Tampa | Florida | United States | 33613 |
| 46 | Site reference ID 163 | Columbus | Georgia | United States | 31904 |
| 47 | Site reference ID 158 | Norcross | Georgia | United States | 30092 |
| 48 | Site reference ID 151 | Norcross | Georgia | United States | 30093 |
| 49 | Site reference ID 150 | Sandy Springs | Georgia | United States | 30328 |
| 50 | Site reference ID 359 | Idaho Falls | Idaho | United States | 83404 |
| 51 | Site reference ID 352 | Meridian | Idaho | United States | 83642 |
| 52 | Site reference ID 174 | Champaign | Illinois | United States | 61820 |
| 53 | Site reference ID 182 | Oak Brook | Illinois | United States | 60523 |
| 54 | Site reference ID 178 | Shawnee Mission | Kansas | United States | 66218 |
| 55 | Site reference ID 354 | Wichita | Kansas | United States | 67207 |
| 56 | Site reference ID 176 | Lake Charles | Louisiana | United States | 70601 |
| 57 | Site reference ID 109 | Marrero | Louisiana | United States | 70072 |
| 58 | Site reference ID 248 | Frederick | Maryland | United States | 21702 |
| 59 | Site reference ID 226 | Silver Spring | Maryland | United States | 20910 |
| 60 | Site reference ID 228 | Towson | Maryland | United States | 21204 |
| 61 | Site reference ID 149 | Fall River | Massachusetts | United States | 02720 |
| 62 | Site reference ID 126 | Fall River | Massachusetts | United States | 02721 |
| 63 | Site reference ID 100 | Bay City | Michigan | United States | 48706 |
| 64 | Site reference ID 145 | Detroit | Michigan | United States | 48034 |
| 65 | Site reference ID 214 | Saginaw | Michigan | United States | 48602 |
| 66 | Site reference ID 170 | Saginaw | Michigan | United States | 48604 |
| 67 | Site reference ID 138 | Missoula | Montana | United States | 59808 |
| 68 | Site reference ID 236 | Las Vegas | Nevada | United States | 89109 |
| 69 | Site reference ID 245 | Lawrenceville | New Jersey | United States | 08648 |
| 70 | Site reference ID 175 | Brooklyn | New York | United States | 11203 |
| 71 | Site reference ID 188 | New York | New York | United States | 10016 |
| 72 | Site reference ID 208 | Port Jefferson | New York | United States | 11764 |
| 73 | Site reference ID 133 | Staten Island | New York | United States | 10306 |
| 74 | Site reference ID 104 | Greensboro | North Carolina | United States | 27408 |
| 75 | Site reference ID 131 | Morehead City | North Carolina | United States | 28557 |
| 76 | Site reference ID 102 | Raleigh | North Carolina | United States | 27607 |
| 77 | Site reference ID 187 | Southern Pines | North Carolina | United States | 28374 |
| 78 | Site reference ID 119 | Winston-Salem | North Carolina | United States | 27103 |
| 79 | Site reference ID 186 | Cincinnati | Ohio | United States | 45212 |
| 80 | Site reference ID 164 | Cleveland | Ohio | United States | 44122 |
| 81 | Site reference ID 230 | Fairfield | Ohio | United States | 45014 |
| 82 | Site reference ID 213 | Franklin | Ohio | United States | 45005 |
| 83 | Site reference ID 116 | Bryn Mawr | Pennsylvania | United States | 19010 |
| 84 | Site reference ID 195 | Hershey | Pennsylvania | United States | 17033 |
| 85 | Site reference ID 222 | Indiana | Pennsylvania | United States | 15701 |
| 86 | Site reference ID 165 | Jenkintown | Pennsylvania | United States | 19046 |
| 87 | Site reference ID 210 | Pittsburgh | Pennsylvania | United States | 15243 |
| 88 | Site reference ID 148 | Smithfield | Pennsylvania | United States | 15478 |
| 89 | Site reference ID 351 | North Charleston | South Carolina | United States | 29406 |
| 90 | Site reference ID 358 | Spartanburg | South Carolina | United States | 29301 |
| 91 | Site reference ID 159 | Chattanooga | Tennessee | United States | 37404 |
| 92 | Site reference ID 235 | Knoxville | Tennessee | United States | 37920 |
| 93 | Site reference ID 205 | Memphis | Tennessee | United States | 38119 |
| 94 | Site reference ID 180 | Memphis | Tennessee | United States | 38120 |
| 95 | Site reference ID 238 | Austin | Texas | United States | 78726 |
| 96 | Site reference ID 155 | Austin | Texas | United States | 78758 |
| 97 | Site reference ID 201 | Beaumont | Texas | United States | 77702 |
| 98 | Site reference ID 247 | Corpus Christi | Texas | United States | 78412 |
| 99 | Site reference ID 183 | Dallas | Texas | United States | 75231 |
| 100 | Site reference ID 216 | Dallas | Texas | United States | 75231 |
| 101 | Site reference ID 200 | Dallas | Texas | United States | 75234 |
| 102 | Site reference ID 250 | Fort Worth | Texas | United States | 76104 |
| 103 | Site reference ID 244 | Fort Worth | Texas | United States | 76132 |
| 104 | Site reference ID 115 | Frisco | Texas | United States | 75035 |
| 105 | Site reference ID 157 | Houston | Texas | United States | 77030 |
| 106 | Site reference ID 120 | Houston | Texas | United States | 77054 |
| 107 | Site reference ID 219 | Houston | Texas | United States | 77071 |
| 108 | Site reference ID 217 | Houston | Texas | United States | 77074 |
| 109 | Site reference ID 218 | Pasadena | Texas | United States | 77505 |
| 110 | Site reference ID 172 | San Antonio | Texas | United States | 78258 |
| 111 | Site reference ID 128 | Webster | Texas | United States | 77598 |
| 112 | Site reference ID 125 | West Jordan | Utah | United States | 84088 |
| 113 | Site reference ID 103 | Norfolk | Virginia | United States | 23507 |
| 114 | Site reference ID 171 | Norfolk | Virginia | United States | 23507 |
| 115 | Site reference ID 123 | Richmond | Virginia | United States | 23233 |
| 116 | Site reference ID 237 | Bellevue | Washington | United States | 98007 |
Sponsors and Collaborators
- ObsEva SA
Investigators
- Study Director: ObsEva SA, Geneva
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
ObsEva SA
ClinicalTrials.gov Identifier:
NCT03070899
Other Study ID Numbers:
- 16-OBE2109-008
First Posted:
Mar 6, 2017
Last Update Posted:
Jun 9, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ObsEva SA
Additional relevant MeSH terms: