Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PRIMROSE 2)
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| ClinicalTrials.gov Identifier: NCT03070951 |
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Recruitment Status :
Completed
First Posted : March 6, 2017
Last Update Posted : March 5, 2021
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Sponsor:
ObsEva SA
Information provided by (Responsible Party):
ObsEva SA
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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: OBE2109 Drug: Placebo to match OBE2109 Drug: Placebo to match Add-back Drug: Add-back | Phase 3 |
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) |
| Actual Enrollment : | 511 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 : | May 23, 2017 |
| Actual Primary Completion Date : | September 16, 2019 |
| Actual Study Completion Date : | October 4, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| 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 |
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 :
- Time to reduced menstrual blood loss [ Time Frame: Up to Week 52 ]Assessed using the alkaline hematin method
- Amenorrhea [ Time Frame: Up to Week 52 ]Assessed using the alkaline hematin method
- Time to amenorrhea [ Time Frame: 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
- 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 76 ]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 76 ]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): NCT03070951
Locations
Show 96 study locations
Sponsors and Collaborators
ObsEva SA
Investigators
| Study Director: | ObsEva SA | Geneva |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ObsEva SA |
| ClinicalTrials.gov Identifier: | NCT03070951 |
| Other Study ID Numbers: |
16-OBE2109-009 |
| First Posted: | March 6, 2017 Key Record Dates |
| Last Update Posted: | March 5, 2021 |
| Last Verified: | March 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by ObsEva SA:
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Uterine Fibroid Leiomyomata Heavy Menstrual Bleeding HMB |
Heavy Uterine Bleeding Menorrhagia OBE2109 + Add-back |
Additional relevant MeSH terms:
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Leiomyoma Myofibroma Menorrhagia Hemorrhage 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 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Menstruation Disturbances |