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

NCT03070951 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 16-OBE2109-009
• Study Type: interventional
• Target: 511
• Locations: 9 countries
• Sites: 96

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.

Conditions

Uterine Fibroids; Heavy Menstrual Bleeding

Keywords

Uterine Fibroid; Leiomyomata; Heavy Menstrual Bleeding; HMB; Heavy Uterine Bleeding; Menorrhagia; OBE2109 + Add-back

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24

  Assessed using the alkaline hematin method

  From baseline to Week 24

Secondary Outcomes (5)

• Time to reduced menstrual blood loss

  Up to Week 52

• Amenorrhea

  Up to Week 52

• 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

• Number of days of uterine bleeding for each 28-day interval

  Up to Week 52

Other Outcomes (3)

• Bone Mineral Density (BMD)

  From baseline up to Week 76

• Endometrial biopsy

  From baseline up to Week 52

• Adverse events

  Up to Week 76

Study Arms (5)

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

EXPERIMENTAL

Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Placebo to match Add-back

OBE2109 dose 1 (100mg) + Add-back

EXPERIMENTAL

Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Add-back

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

EXPERIMENTAL

Drug: OBE2109; Drug: Placebo to match Add-back; Drug: Add-back

OBE2109 dose 2 (200mg) + Add-back

EXPERIMENTAL

Drug: OBE2109; Drug: Add-back

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

PLACEBO COMPARATOR

Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Placebo to match Add-back; Drug: Add-back

Interventions

OBE2109 DRUG

OBE2109 100mg tablets for oral administration once daily

OBE2109 dose 1 (100mg) + Add-back; OBE2109 dose 1 (100mg) + Placebo Add-back; OBE2109 dose 2 (200mg) + Add-back; OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back; Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back

Placebo to match OBE2109 DRUG

Placebo to match OBE2109 100mg tablets for oral administration once daily

OBE2109 dose 1 (100mg) + Add-back; OBE2109 dose 1 (100mg) + Placebo Add-back; Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back

Placebo to match Add-back DRUG

Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

OBE2109 dose 1 (100mg) + Placebo Add-back; OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back; Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back

Add-back DRUG

Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

OBE2109 dose 1 (100mg) + Add-back; OBE2109 dose 2 (200mg) + Add-back; OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back; Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ObsEva SA: lead

Study Sites (96)

Site reference ID 905

Chino, California, 91710, United States

Location

Site reference ID 918

Huntington Park, California, 29572, United States

Location

Site reference ID 902

San Diego, California, 92123, United States

Location

Site reference ID 903

Denver, Colorado, 80209, United States

Location

Site reference ID 913

Bradenton, Florida, 34209, United States

Location

Site reference ID 912

Orlando, Florida, 32806, United States

Location

Site reference ID 915

Augusta, Georgia, 30912, United States

Location

Site reference ID 924

Nampa, Idaho, 83687, United States

Location

Site reference ID 926

Covington, Louisiana, 70433, United States

Location

Site reference ID 927

Metairie, Louisiana, 70006, United States

Location

Site reference ID 900

Metairie, Louisiana, 92123, United States

Location

Site reference ID 901

Canton, Michigan, 48187, United States

Location

Site reference ID 932

Detroit, Michigan, 48201, United States

Location

Site reference ID 916

Jefferson City, Missouri, 65109, United States

Location

Site reference ID 930

Albuquerque, New Mexico, 87102, United States

Location

Site reference ID 933

West Seneca, New York, 14224, United States

Location

Site reference ID 931

Hamlet, North Carolina, 28345, United States

Location

Site reference ID 914

Westerville, Ohio, 43081, United States

Location

Site reference ID 928

Erie, Pennsylvania, 16507, United States

Location

Site reference ID 919

West Columbia, South Carolina, 37203, United States

Location

Site reference ID 907

Houston, Texas, 77058, United States

Location

Site reference ID 911

Salt Lake City, Utah, 84124, United States

Location

Site reference ID 917

Madison, Wisconsin, 53717, United States

Location

Site reference ID 265

Gabrovo, Bulgaria

Location

Site reference ID 255

Pleven, Bulgaria

Location

Site reference ID 258

Plovdiv, Bulgaria

Location

Site reference ID 266

Sliven, Bulgaria

Location

Site reference ID 264

Smolyan, Bulgaria

Location

Site reference ID 251

Sofia, Bulgaria

Location

Site reference ID 252

Sofia, Bulgaria

Location

Site reference ID 254

Sofia, Bulgaria

Location

Site reference ID 256

Sofia, Bulgaria

Location

Site reference ID 257

Sofia, Bulgaria

Location

Site reference ID 267

Sofia, Bulgaria

Location

Site reference ID 285

České Budějovice, Czechia

Location

Site reference ID 283

Písek, Czechia

Location

Site reference ID 281

Prague, Czechia

Location

Site reference ID 286

Prague, Czechia

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Site reference ID 287

Prague, Czechia

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Site reference ID 288

Prague, Czechia

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Site reference ID 284

Příbram, Czechia

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Site reference ID 289

Tábor, Czechia

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Site reference ID 282

Vsetín, Czechia

Location

Site reference ID 315

Baja, Hungary

Location

Site reference ID 303

Budapest, Hungary

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Site reference ID 307

Budapest, Hungary

Location

Site reference ID 301

Debrecen, Hungary

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Site reference ID 308

Debrecen, Hungary

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Site reference ID 313

Debrecen, Hungary

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Site reference ID 314

Kecskemét, Hungary

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Site reference ID 304

Kistarcsa, Hungary

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Site reference ID 306

Nyíregyháza, Hungary

Location

Site reference ID 451

Riga, Latvia

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Site reference ID 452

Riga, Latvia

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Site reference ID 454

Riga, Latvia

Location

Site reference ID 463

Kaunas, Lithuania

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Site reference ID 460

Vilnius, Lithuania

Location

Site reference ID 461

Vilnius, Lithuania

Location

Site reference ID 464

Vilnius, Lithuania

Location

Site reference ID 502

Bialystok, Poland

Location

Site reference ID 504

Katowice, Poland

Location

Site reference ID 509

Katowice, Poland

Location

Site reference ID 513

Katowice, Poland

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Site reference ID 514

Katowice, Poland

Location

Site reference ID 501

Knurów, Poland

Location

Site reference ID 510

Lodz, Poland

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Site reference ID 517

Lodz, Poland

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Site reference ID 506

Lublin, Poland

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Site reference ID 508

Lublin, Poland

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Site reference ID 511

Lublin, Poland

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Site reference ID 519

Piaseczno, Poland

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Site reference ID 518

Poznan, Poland

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Site reference ID 505

Przemyśl, Poland

Location

Site reference ID 503

Szczecin, Poland

Location

Site reference ID 512

Świdnik, Poland

Location

Site reference ID 507

Warsaw, Poland

Location

Site reference ID 606

Brasov, Romania

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Site reference ID 601

Bucharest, Romania

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Site reference ID 603

Bucharest, Romania

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Site reference ID 604

Bucharest, Romania

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Site reference ID 605

Târgu Mureş, Romania

Location

Site reference ID 813

Chernivtsi, Ukraine

Location

Site reference ID 801

Ivano-Frankivsk, Ukraine

Location

Site reference ID 814

Kharkiv, Ukraine

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Site reference ID 802

Kyiv, Ukraine

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Site reference ID 803

Kyiv, Ukraine

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Site reference ID 805

Kyiv, Ukraine

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Site reference ID 806

Kyiv, Ukraine

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Site reference ID 807

Kyiv, Ukraine

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Site reference ID 804

Lviv, Ukraine

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Site reference ID 811

Odesa, Ukraine

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Site reference ID 808

Ternopil, Ukraine

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Site reference ID 817

Vinnytsia, Ukraine

Location

Site reference ID 812

Zaporizhzhya, Ukraine

Location

Site reference ID 815

Zaporizhzhya, Ukraine

Location

Site reference ID 816

Zaporizhzhya, Ukraine

Location

Related Publications (3)

• Donnez J, Petraglia F, Taylor H, Becker CM, Becker S, Herrera FC, Bestel E, Hori S, Dolmans MM. Linzagolix with and without hormonal add-back therapy for symptomatic uterine fibroids: PRIMROSE 1 & 2 long-term extension and withdrawal study. Fertil Steril. 2025 Oct;124(4):737-748. doi: 10.1016/j.fertnstert.2025.06.016. Epub 2025 Jun 19.

  PMID: 40543832 DERIVED

• Becker S, Dolmans MM, Herrera FC, Petraglia F, Renner SP, Ionescu-Ittu R, St-Pierre J, Boolell M, Bestel E, Hori S, Donnez J. Pain Reduction in Linzagolix-Treated Patients With Uterine Fibroids: A Secondary Mediation Analysis of the PRIMROSE 1 and 2 Phase 3 Trials. BJOG. 2025 Aug;132(9):1297-1306. doi: 10.1111/1471-0528.18190. Epub 2025 May 6.

  PMID: 40326221 DERIVED

• 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.

  PMID: 36116480 DERIVED

MeSH Terms

Conditions

Leiomyoma; Menorrhagia

Interventions

linzagolix

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• ObsEva SA

  Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: March 6, 2017
• Study Start: May 23, 2017
• Primary Completion: September 16, 2019
• Study Completion: October 4, 2020
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

UA (15); BU (11); HU (9); LA (3); US (23); LI (4); PL (17); RO (5); CZ (9)