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

NCT ID: NCT03070951

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2020-10-04

Brief Summary

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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.

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A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain

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CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women

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Detailed Description

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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.

Conditions

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Uterine Fibroids Heavy Menstrual Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

OBE2109

Intervention Type DRUG

OBE2109 100mg tablets for oral administration once daily

Placebo to match OBE2109

Intervention Type DRUG

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

Placebo to match Add-back

Intervention Type DRUG

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

OBE2109 dose 1 (100mg) + Add-back

Group Type EXPERIMENTAL

OBE2109

Intervention Type DRUG

OBE2109 100mg tablets for oral administration once daily

Placebo to match OBE2109

Intervention Type DRUG

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

Add-back

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

OBE2109

Intervention Type DRUG

OBE2109 100mg tablets for oral administration once daily

Placebo to match Add-back

Intervention Type DRUG

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

Add-back

Intervention Type DRUG

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

OBE2109 dose 2 (200mg) + Add-back

Group Type EXPERIMENTAL

OBE2109

Intervention Type DRUG

OBE2109 100mg tablets for oral administration once daily

Add-back

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

OBE2109

Intervention Type DRUG

OBE2109 100mg tablets for oral administration once daily

Placebo to match OBE2109

Intervention Type DRUG

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

Placebo to match Add-back

Intervention Type DRUG

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

Add-back

Intervention Type DRUG

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

Interventions

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OBE2109

OBE2109 100mg tablets for oral administration once daily

Intervention Type DRUG

Placebo to match OBE2109

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

Intervention Type DRUG

Placebo to match Add-back

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

Intervention Type DRUG

Add-back

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

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ObsEva SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ObsEva SA

Role: STUDY_DIRECTOR

Geneva

Locations

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Site reference ID 905

Chino, California, United States

Site Status

Site reference ID 918

Huntington Park, California, United States

Site Status

Site reference ID 902

San Diego, California, United States

Site Status

Site reference ID 903

Denver, Colorado, United States

Site Status

Site reference ID 913

Bradenton, Florida, United States

Site Status

Site reference ID 912

Orlando, Florida, United States

Site Status

Site reference ID 915

Augusta, Georgia, United States

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Site reference ID 924

Nampa, Idaho, United States

Site Status

Site reference ID 926

Covington, Louisiana, United States

Site Status

Site reference ID 927

Metairie, Louisiana, United States

Site Status

Site reference ID 900

Metairie, Louisiana, United States

Site Status

Site reference ID 901

Canton, Michigan, United States

Site Status

Site reference ID 932

Detroit, Michigan, United States

Site Status

Site reference ID 916

Jefferson City, Missouri, United States

Site Status

Site reference ID 930

Albuquerque, New Mexico, United States

Site Status

Site reference ID 933

West Seneca, New York, United States

Site Status

Site reference ID 931

Hamlet, North Carolina, United States

Site Status

Site reference ID 914

Westerville, Ohio, United States

Site Status

Site reference ID 928

Erie, Pennsylvania, United States

Site Status

Site reference ID 919

West Columbia, South Carolina, United States

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Site reference ID 907

Houston, Texas, United States

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Site reference ID 911

Salt Lake City, Utah, United States

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Site reference ID 917

Madison, Wisconsin, United States

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Site reference ID 265

Gabrovo, , Bulgaria

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Site reference ID 255

Pleven, , Bulgaria

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Site reference ID 258

Plovdiv, , Bulgaria

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Site reference ID 266

Sliven, , Bulgaria

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Site reference ID 264

Smolyan, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Site reference ID 267

Sofia, , Bulgaria

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Site reference ID 285

České Budějovice, , Czechia

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Site reference ID 283

Písek, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Příbram, , Czechia

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Tábor, , Czechia

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Vsetín, , Czechia

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Site reference ID 315

Baja, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Debrecen, , Hungary

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Debrecen, , Hungary

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Kecskemét, , Hungary

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Kistarcsa, , Hungary

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Nyíregyháza, , Hungary

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Bialystok, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Knurów, , Poland

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Site reference ID 510

Lodz, , Poland

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Lodz, , Poland

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Lublin, , Poland

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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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Przemyśl, , Poland

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Szczecin, , Poland

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Site reference ID 512

Świdnik, , Poland

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Warsaw, , Poland

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Site reference ID 606

Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Site reference ID 605

Târgu Mureş, , Romania

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Site reference ID 813

Chernivtsi, , Ukraine

Site Status

Site reference ID 801

Ivano-Frankivsk, , Ukraine

Site Status

Site reference ID 814

Kharkiv, , Ukraine

Site Status

Site reference ID 802

Kyiv, , Ukraine

Site Status

Site reference ID 803

Kyiv, , Ukraine

Site Status

Site reference ID 805

Kyiv, , Ukraine

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Site reference ID 806

Kyiv, , Ukraine

Site Status

Site reference ID 807

Kyiv, , Ukraine

Site Status

Site reference ID 804

Lviv, , Ukraine

Site Status

Site reference ID 811

Odesa, , Ukraine

Site Status

Site reference ID 808

Ternopil, , Ukraine

Site Status

Site reference ID 817

Vinnytsia, , Ukraine

Site Status

Site reference ID 812

Zaporizhzhya, , Ukraine

Site Status

Site reference ID 815

Zaporizhzhya, , Ukraine

Site Status

Site reference ID 816

Zaporizhzhya, , Ukraine

Site Status

Countries

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United States Bulgaria Czechia Hungary Latvia Lithuania Poland Romania Ukraine

References

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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.

Reference Type DERIVED
PMID: 40543832 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40326221 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36116480 (View on PubMed)

Other Identifiers

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16-OBE2109-009

Identifier Type: -

Identifier Source: org_study_id

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