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Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 2)

Primary Purpose

Uterine Fibroids, Heavy Menstrual Bleeding

Status
Completed
Phase
Phase 3
Locations
International
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 905
  • Site reference ID 918
  • Site reference ID 902
  • Site reference ID 903
  • Site reference ID 913
  • Site reference ID 912
  • Site reference ID 915
  • Site reference ID 924
  • Site reference ID 926
  • Site reference ID 927
  • Site reference ID 900
  • Site reference ID 901
  • Site reference ID 932
  • Site reference ID 916
  • Site reference ID 930
  • Site reference ID 933
  • Site reference ID 931
  • Site reference ID 914
  • Site reference ID 928
  • Site reference ID 919
  • Site reference ID 907
  • Site reference ID 911
  • Site reference ID 917
  • Site reference ID 265
  • Site reference ID 255
  • Site reference ID 258
  • Site reference ID 266
  • Site reference ID 264
  • Site reference ID 251
  • Site reference ID 252
  • Site reference ID 254
  • Site reference ID 256
  • Site reference ID 257
  • Site reference ID 267
  • Site reference ID 281
  • Site reference ID 286
  • Site reference ID 287
  • Site reference ID 288
  • Site reference ID 283
  • Site reference ID 284
  • Site reference ID 289
  • Site reference ID 282
  • Site reference ID 285
  • Site reference ID 315
  • Site reference ID 303
  • Site reference ID 307
  • Site reference ID 301
  • Site reference ID 308
  • Site reference ID 313
  • Site reference ID 314
  • Site reference ID 304
  • Site reference ID 306
  • Site reference ID 451
  • Site reference ID 452
  • Site reference ID 454
  • Site reference ID 463
  • Site reference ID 460
  • Site reference ID 461
  • Site reference ID 464
  • Site reference ID 502
  • Site reference ID 504
  • Site reference ID 509
  • Site reference ID 513
  • Site reference ID 514
  • Site reference ID 501
  • Site reference ID 506
  • Site reference ID 508
  • Site reference ID 511
  • Site reference ID 519
  • Site reference ID 518
  • Site reference ID 505
  • Site reference ID 503
  • Site reference ID 507
  • Site reference ID 510
  • Site reference ID 517
  • Site reference ID 512
  • Site reference ID 606
  • Site reference ID 601
  • Site reference ID 603
  • Site reference ID 604
  • Site reference ID 605
  • Site reference ID 813
  • Site reference ID 801
  • Site reference ID 814
  • Site reference ID 802
  • Site reference ID 803
  • Site reference ID 805
  • Site reference ID 806
  • Site reference ID 807
  • Site reference ID 804
  • Site reference ID 811
  • Site reference ID 808
  • Site reference ID 817
  • Site reference ID 812
  • Site reference ID 815
  • Site reference ID 816

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

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
March 3, 2021
Sponsor
ObsEva SA
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1. Study Identification

Unique Protocol Identification Number
NCT03070951
Brief Title
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Acronym
PRIMROSE 2
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
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
September 16, 2019 (Actual)
Study Completion Date
October 4, 2020 (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
511 (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
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 905
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Site reference ID 918
City
Huntington Park
State/Province
California
ZIP/Postal Code
29572
Country
United States
Facility Name
Site reference ID 902
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site reference ID 903
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Site reference ID 913
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Site reference ID 912
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site reference ID 915
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Site reference ID 924
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Site reference ID 926
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Site reference ID 927
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Site reference ID 900
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
92123
Country
United States
Facility Name
Site reference ID 901
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Facility Name
Site reference ID 932
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Site reference ID 916
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Site reference ID 930
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Site reference ID 933
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Site reference ID 931
City
Hamlet
State/Province
North Carolina
ZIP/Postal Code
28345
Country
United States
Facility Name
Site reference ID 914
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Site reference ID 928
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
Site reference ID 919
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
37203
Country
United States
Facility Name
Site reference ID 907
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Site reference ID 911
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Site reference ID 917
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
Site reference ID 265
City
Gabrovo
Country
Bulgaria
Facility Name
Site reference ID 255
City
Pleven
Country
Bulgaria
Facility Name
Site reference ID 258
City
Plovdiv
Country
Bulgaria
Facility Name
Site reference ID 266
City
Sliven
Country
Bulgaria
Facility Name
Site reference ID 264
City
Smolyan
Country
Bulgaria
Facility Name
Site reference ID 251
City
Sofia
Country
Bulgaria
Facility Name
Site reference ID 252
City
Sofia
Country
Bulgaria
Facility Name
Site reference ID 254
City
Sofia
Country
Bulgaria
Facility Name
Site reference ID 256
City
Sofia
Country
Bulgaria
Facility Name
Site reference ID 257
City
Sofia
Country
Bulgaria
Facility Name
Site reference ID 267
City
Sofia
Country
Bulgaria
Facility Name
Site reference ID 281
City
Praha
Country
Czechia
Facility Name
Site reference ID 286
City
Praha
Country
Czechia
Facility Name
Site reference ID 287
City
Praha
Country
Czechia
Facility Name
Site reference ID 288
City
Praha
Country
Czechia
Facility Name
Site reference ID 283
City
Písek
Country
Czechia
Facility Name
Site reference ID 284
City
Příbram
Country
Czechia
Facility Name
Site reference ID 289
City
Tábor
Country
Czechia
Facility Name
Site reference ID 282
City
Vsetín
Country
Czechia
Facility Name
Site reference ID 285
City
České Budějovice
Country
Czechia
Facility Name
Site reference ID 315
City
Baja
Country
Hungary
Facility Name
Site reference ID 303
City
Budapest
Country
Hungary
Facility Name
Site reference ID 307
City
Budapest
Country
Hungary
Facility Name
Site reference ID 301
City
Debrecen
Country
Hungary
Facility Name
Site reference ID 308
City
Debrecen
Country
Hungary
Facility Name
Site reference ID 313
City
Debrecen
Country
Hungary
Facility Name
Site reference ID 314
City
Kecskemét
Country
Hungary
Facility Name
Site reference ID 304
City
Kistarcsa
Country
Hungary
Facility Name
Site reference ID 306
City
Nyíregyháza
Country
Hungary
Facility Name
Site reference ID 451
City
Riga
Country
Latvia
Facility Name
Site reference ID 452
City
Riga
Country
Latvia
Facility Name
Site reference ID 454
City
Riga
Country
Latvia
Facility Name
Site reference ID 463
City
Kaunas
Country
Lithuania
Facility Name
Site reference ID 460
City
Vilnius
Country
Lithuania
Facility Name
Site reference ID 461
City
Vilnius
Country
Lithuania
Facility Name
Site reference ID 464
City
Vilnius
Country
Lithuania
Facility Name
Site reference ID 502
City
Białystok
Country
Poland
Facility Name
Site reference ID 504
City
Katowice
Country
Poland
Facility Name
Site reference ID 509
City
Katowice
Country
Poland
Facility Name
Site reference ID 513
City
Katowice
Country
Poland
Facility Name
Site reference ID 514
City
Katowice
Country
Poland
Facility Name
Site reference ID 501
City
Knurów
Country
Poland
Facility Name
Site reference ID 506
City
Lublin
Country
Poland
Facility Name
Site reference ID 508
City
Lublin
Country
Poland
Facility Name
Site reference ID 511
City
Lublin
Country
Poland
Facility Name
Site reference ID 519
City
Piaseczno
Country
Poland
Facility Name
Site reference ID 518
City
Poznań
Country
Poland
Facility Name
Site reference ID 505
City
Przemyśl
Country
Poland
Facility Name
Site reference ID 503
City
Szczecin
Country
Poland
Facility Name
Site reference ID 507
City
Warsaw
Country
Poland
Facility Name
Site reference ID 510
City
Łódź
Country
Poland
Facility Name
Site reference ID 517
City
Łódź
Country
Poland
Facility Name
Site reference ID 512
City
Świdnik
Country
Poland
Facility Name
Site reference ID 606
City
Braşov
Country
Romania
Facility Name
Site reference ID 601
City
Bucuresti
Country
Romania
Facility Name
Site reference ID 603
City
Bucuresti
Country
Romania
Facility Name
Site reference ID 604
City
Bucuresti
Country
Romania
Facility Name
Site reference ID 605
City
Târgu-Mureş
Country
Romania
Facility Name
Site reference ID 813
City
Chernivtsi
Country
Ukraine
Facility Name
Site reference ID 801
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
Site reference ID 814
City
Kharkiv
Country
Ukraine
Facility Name
Site reference ID 802
City
Kyiv
Country
Ukraine
Facility Name
Site reference ID 803
City
Kyiv
Country
Ukraine
Facility Name
Site reference ID 805
City
Kyiv
Country
Ukraine
Facility Name
Site reference ID 806
City
Kyiv
Country
Ukraine
Facility Name
Site reference ID 807
City
Kyiv
Country
Ukraine
Facility Name
Site reference ID 804
City
L'viv
Country
Ukraine
Facility Name
Site reference ID 811
City
Odesa
Country
Ukraine
Facility Name
Site reference ID 808
City
Ternopil'
Country
Ukraine
Facility Name
Site reference ID 817
City
Vinnytsia
Country
Ukraine
Facility Name
Site reference ID 812
City
Zaporizhzhya
Country
Ukraine
Facility Name
Site reference ID 815
City
Zaporizhzhya
Country
Ukraine
Facility Name
Site reference ID 816
City
Zaporizhzhya
Country
Ukraine

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

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

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