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

March 3, 2021 updated by: ObsEva SA

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
511

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Gabrovo, Bulgaria
        • Site reference ID 265
      • Pleven, Bulgaria
        • Site reference ID 255
      • Plovdiv, Bulgaria
        • Site reference ID 258
      • Sliven, Bulgaria
        • Site reference ID 266
      • Smolyan, Bulgaria
        • Site reference ID 264
      • Sofia, Bulgaria
        • Site reference ID 251
      • Sofia, Bulgaria
        • Site reference ID 252
      • Sofia, Bulgaria
        • Site reference ID 254
      • Sofia, Bulgaria
        • Site reference ID 256
      • Sofia, Bulgaria
        • Site reference ID 257
      • Sofia, Bulgaria
        • Site reference ID 267
  • Czechia
      • Praha, Czechia
        • Site reference ID 281
      • Praha, Czechia
        • Site reference ID 286
      • Praha, Czechia
        • Site reference ID 287
      • Praha, Czechia
        • Site reference ID 288
      • Písek, Czechia
        • Site reference ID 283
      • Příbram, Czechia
        • Site reference ID 284
      • Tábor, Czechia
        • Site reference ID 289
      • Vsetín, Czechia
        • Site reference ID 282
      • České Budějovice, Czechia
        • Site reference ID 285
  • Hungary
      • Baja, Hungary
        • Site reference ID 315
      • Budapest, Hungary
        • Site reference ID 303
      • Budapest, Hungary
        • Site reference ID 307
      • Debrecen, Hungary
        • Site reference ID 301
      • Debrecen, Hungary
        • Site reference ID 308
      • Debrecen, Hungary
        • Site reference ID 313
      • Kecskemét, Hungary
        • Site reference ID 314
      • Kistarcsa, Hungary
        • SIte reference ID 304
      • Nyíregyháza, Hungary
        • Site reference ID 306
  • Latvia
      • Riga, Latvia
        • Site reference ID 451
      • Riga, Latvia
        • Site reference ID 452
      • Riga, Latvia
        • Site reference ID 454
  • Lithuania
      • Kaunas, Lithuania
        • Site reference ID 463
      • Vilnius, Lithuania
        • Site reference ID 460
      • Vilnius, Lithuania
        • Site reference ID 461
      • Vilnius, Lithuania
        • Site reference ID 464
  • Poland
      • Białystok, Poland
        • Site reference ID 502
      • Katowice, Poland
        • Site reference ID 504
      • Katowice, Poland
        • Site reference ID 509
      • Katowice, Poland
        • Site reference ID 513
      • Katowice, Poland
        • Site reference ID 514
      • Knurów, Poland
        • Site reference ID 501
      • Lublin, Poland
        • Site reference ID 506
      • Lublin, Poland
        • Site reference ID 508
      • Lublin, Poland
        • Site reference ID 511
      • Piaseczno, Poland
        • Site reference ID 519
      • Poznań, Poland
        • Site reference ID 518
      • Przemyśl, Poland
        • Site reference ID 505
      • Szczecin, Poland
        • Site reference ID 503
      • Warsaw, Poland
        • Site reference ID 507
      • Łódź, Poland
        • Site reference ID 510
      • Łódź, Poland
        • Site reference ID 517
      • Świdnik, Poland
        • Site reference ID 512
  • Romania
      • Braşov, Romania
        • Site reference ID 606
      • Bucuresti, Romania
        • Site reference ID 601
      • Bucuresti, Romania
        • Site reference ID 603
      • Bucuresti, Romania
        • Site reference ID 604
      • Târgu-Mureş, Romania
        • Site reference ID 605
  • Ukraine
      • Chernivtsi, Ukraine
        • Site reference ID 813
      • Ivano-Frankivs'k, Ukraine
        • Site reference ID 801
      • Kharkiv, Ukraine
        • Site reference ID 814
      • Kyiv, Ukraine
        • Site reference ID 802
      • Kyiv, Ukraine
        • Site reference ID 803
      • Kyiv, Ukraine
        • Site reference ID 805
      • Kyiv, Ukraine
        • Site reference ID 806
      • Kyiv, Ukraine
        • Site reference ID 807
      • L'viv, Ukraine
        • Site reference ID 804
      • Odesa, Ukraine
        • Site reference ID 811
      • Ternopil', Ukraine
        • Site reference ID 808
      • Vinnytsia, Ukraine
        • Site reference ID 817
      • Zaporizhzhya, Ukraine
        • Site reference ID 812
      • Zaporizhzhya, Ukraine
        • Site reference ID 815
      • Zaporizhzhya, Ukraine
        • Site reference ID 816
  • United States
    • California
      • Chino, California, United States, 91710
        • Site reference ID 905
      • Huntington Park, California, United States, 29572
        • Site reference ID 918
      • San Diego, California, United States, 92123
        • Site reference ID 902
    • Colorado
      • Denver, Colorado, United States, 80209
        • Site reference ID 903
    • Florida
      • Bradenton, Florida, United States, 34209
        • Site reference ID 913
      • Orlando, Florida, United States, 32806
        • Site reference ID 912
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Site reference ID 915
    • Idaho
      • Nampa, Idaho, United States, 83687
        • Site reference ID 924
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Site reference ID 926
      • Metairie, Louisiana, United States, 70006
        • Site reference ID 927
      • Metairie, Louisiana, United States, 92123
        • Site reference ID 900
    • Michigan
      • Canton, Michigan, United States, 48187
        • Site reference ID 901
      • Detroit, Michigan, United States, 48201
        • Site reference ID 932
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Site reference ID 916
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Site reference ID 930
    • New York
      • West Seneca, New York, United States, 14224
        • Site reference ID 933
    • North Carolina
      • Hamlet, North Carolina, United States, 28345
        • Site reference ID 931
    • Ohio
      • Westerville, Ohio, United States, 43081
        • Site reference ID 914
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Site reference ID 928
    • South Carolina
      • West Columbia, South Carolina, United States, 37203
        • Site reference ID 919
    • Texas
      • Houston, Texas, United States, 77058
        • Site reference ID 907
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Site reference ID 911
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • Site reference ID 917

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24
Time Frame: From baseline to Week 24
Assessed using the alkaline hematin method
From baseline to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to reduced menstrual blood loss
Time Frame: Up to Week 52
Assessed using the alkaline hematin method
Up to Week 52
Amenorrhea
Time Frame: Up to Week 52
Assessed using the alkaline hematin method
Up to Week 52
Time to amenorrhea
Time Frame: Up to Week 52
Up to Week 52
Number of days of uterine bleeding for the last 28-day interval prior to Week 24
Time Frame: last 28-day interval prior to Week 24
Assessed using the alkaline hematin method
last 28-day interval prior to Week 24
Number of days of uterine bleeding for each 28-day interval
Time Frame: Up to Week 52
Assessed using the alkaline hematin method
Up to Week 52

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone Mineral Density (BMD)
Time Frame: From baseline up to Week 76
Assessed by dual-energy X-ray absorptiometry (DXA) scan
From baseline up to Week 76
Endometrial biopsy
Time Frame: From baseline up to Week 52
Assessed by histology
From baseline up to Week 52
Adverse events
Time Frame: Up to Week 76
Frequency and severity of Treatment-Emergent Adverse Events
Up to Week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ObsEva SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ObsEva SA, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-OBE2109-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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