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Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 1)

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ClinicalTrials.gov Identifier: NCT03070899
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
ObsEva SA

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Heavy Menstrual Bleeding Drug: Placebo + Placebo Add-back Drug: OBE2109 + Placebo Add-back Drug: OBE2109 + Add-back Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Amenorrhea [ Time Frame: Up to Week 52 ]
    Assessed using the alkaline hematin method

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

  4. 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:
  1. Bone Mineral Density (BMD) [ Time Frame: From baseline up to Week 52 ]
    Assessed by dual-energy X-ray absorptiometry (DXA) scan

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070899


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

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Sponsors and Collaborators
ObsEva SA
Investigators
Study Director: ObsEva SA Geneva

Responsible Party: ObsEva SA
ClinicalTrials.gov Identifier: NCT03070899     History of Changes
Other Study ID Numbers: 16-OBE2109-008
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: October 2018

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