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Trial record 1 of 1 for:    NCT03070951
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Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 2)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by ObsEva SA
Sponsor:
Information provided by (Responsible Party):
ObsEva SA
ClinicalTrials.gov Identifier:
NCT03070951
First received: February 17, 2017
Last updated: August 15, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Uterine Fibroids Heavy Menstrual Bleeding Drug: Placebo + Placebo Add-back Drug: OBE2109 + Placebo Add-back Drug: OBE2109 + Add-back Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ObsEva SA:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Amenorrhea [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method

  • Time to amenorrhea [ Time Frame: Up to Week 52 ]
  • Time to reduced menstrual blood loss [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method

  • Number of days of uterine bleeding for each 28-day interval [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method


Other Outcome Measures:
  • Bone Mineral Density (BMD) [ Time Frame: From baseline up to Week 52 ]
    Assessed by dual-energy X-ray absorptiometry (DXA) scan

  • Endometrial biopsy [ Time Frame: From baseline up to Week 52 ]
    Assessed by histology

  • Adverse events [ Time Frame: Up to Week 52 ]
    Frequency and severity of Treatment-Emergent Adverse Events


Estimated Enrollment: 500
Actual Study Start Date: May 23, 2017
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OBE2109 dose 1 + Placebo Add-back Drug: OBE2109 + Placebo Add-back
OBE2109 tablets and Placebo Add-back for oral administration once daily
Experimental: OBE2109 dose 1 + Add-back Drug: OBE2109 + Add-back
OBE2109 tablets and Add-back for oral administration once daily
Experimental: OBE2109 dose 2 + Placebo Add-back Drug: OBE2109 + Placebo Add-back
OBE2109 tablets and Placebo Add-back for oral administration once daily
Experimental: OBE2109 dose 2 + Add-back Drug: OBE2109 + Add-back
OBE2109 tablets and Add-back for oral administration once daily
Placebo Comparator: Placebo + Placebo Add-back / OBE2109 dose 3 + Add-back Drug: Placebo + Placebo Add-back
Placebo tablets and Placebo Add-back for oral administration once daily
Drug: OBE2109 + Add-back
OBE2109 tablets and Add-back for oral administration once daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03070951

Contacts
Contact: Chief Medical Officer +41225523840 clinicaltrials@obseva.ch

Locations
United States, California
Site reference ID 918 Recruiting
Huntington Park, California, United States, 29572
United States, Colorado
Site reference ID 903 Recruiting
Denver, Colorado, United States, 80209
United States, Florida
Site reference ID 913 Recruiting
Bradenton, Florida, United States, 34209
Site reference ID 912 Recruiting
Orlando, Florida, United States, 32806
United States, Idaho
Site reference ID 924 Recruiting
Nampa, Idaho, United States, 83687
United States, Louisiana
Site reference ID 900 Recruiting
Metairie, Louisiana, United States, 92123
United States, Michigan
Site reference ID 901 Recruiting
Canton, Michigan, United States, 48187
United States, Ohio
Site reference ID 914 Recruiting
Westerville, Ohio, United States, 43081
United States, South Carolina
Site reference ID 919 Recruiting
West Columbia, South Carolina, United States, 37203
Czechia
Site reference ID 281 Recruiting
Praha, Czechia
Site reference ID 286 Recruiting
Praha, Czechia
Site reference ID 287 Recruiting
Praha, Czechia
Site reference ID 284 Recruiting
Příbram, Czechia
Site reference ID 282 Recruiting
Vsetín, Czechia
Poland
Site reference ID 502 Recruiting
Białystok, Poland
Site reference ID 506 Recruiting
Lublin, Poland
Site reference ID 508 Recruiting
Lublin, Poland
Site reference ID 505 Recruiting
Przemyśl, Poland
Site reference ID 510 Recruiting
Łódź, Poland
Site reference ID 512 Recruiting
Świdnik, Poland
Sponsors and Collaborators
ObsEva SA
Investigators
Study Director: ObsEva SA Geneva
  More Information

Responsible Party: ObsEva SA
ClinicalTrials.gov Identifier: NCT03070951     History of Changes
Other Study ID Numbers: 16-OBE2109-009
Study First Received: February 17, 2017
Last Updated: August 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ObsEva SA:
Uterine Fibroid
Leiomyomata
Heavy Menstrual Bleeding
HMB
Heavy Uterine Bleeding
Menorrhagia
OBE2109 + Add-back

Additional relevant MeSH terms:
Hemorrhage
Leiomyoma
Myofibroma
Menorrhagia
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances

ClinicalTrials.gov processed this record on September 21, 2017