Uterine FibroidsPhase 3PRIMROSE 2NCT03070951
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
A Phase 3 study testing OBE2109 and Add-back in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by ObsEva SA at 96 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids, Heavy Menstrual Bleeding
- What is being tested?
- OBE2109 and Add-back
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 511 participants
- Where
- 96 sitesin 9 countries
- Study dates
- 23 May 2017to 4 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
96 sites in 9 countries.
96 sites in 9 countries
United States23 sites
Site reference ID 930
Albuquerque, New Mexico, 87102
Site reference ID 915
Augusta, Georgia, 30912
Site reference ID 913
Bradenton, Florida, 34209
Site reference ID 901
Canton, Michigan, 48187
Site reference ID 905
Chino, California, 91710
Site reference ID 926
Covington, Louisiana, 70433
Site reference ID 903
Denver, Colorado, 80209
Site reference ID 932
Detroit, Michigan, 48201
Site reference ID 928
Erie, Pennsylvania, 16507
Site reference ID 931
Hamlet, North Carolina, 28345
Site reference ID 907
Houston, Texas, 77058
Site reference ID 918
Huntington Park, California, 29572
Site reference ID 916
Jefferson City, Missouri, 65109
Site reference ID 917
Madison, Wisconsin, 53717
Site reference ID 927
Metairie, Louisiana, 70006
Site reference ID 900
Metairie, Louisiana, 92123
Site reference ID 924
Nampa, Idaho, 83687
Site reference ID 912
Orlando, Florida, 32806
Site reference ID 911
Salt Lake City, Utah, 84124
Site reference ID 902
San Diego, California, 92123
Site reference ID 919
West Columbia, South Carolina, 37203
Site reference ID 933
West Seneca, New York, 14224
Site reference ID 914
Westerville, Ohio, 43081
Poland17 sites
Site reference ID 502
Bialystok
Site reference ID 504
Katowice
Site reference ID 509
Katowice
Site reference ID 513
Katowice
Site reference ID 514
Katowice
Site reference ID 501
Knurów
Site reference ID 510
Lodz
Site reference ID 517
Lodz
Site reference ID 506
Lublin
Site reference ID 508
Lublin
Site reference ID 511
Lublin
Site reference ID 519
Piaseczno
Site reference ID 518
Poznan
Site reference ID 505
Przemyśl
Site reference ID 512
Świdnik
Site reference ID 503
Szczecin
Site reference ID 507
Warsaw
Ukraine15 sites
Site reference ID 813
Chernivtsi
Site reference ID 801
Ivano-Frankivsk
Site reference ID 814
Kharkiv
Site reference ID 802
Kyiv
Site reference ID 803
Kyiv
Site reference ID 805
Kyiv
Site reference ID 806
Kyiv
Site reference ID 807
Kyiv
Site reference ID 804
Lviv
Site reference ID 811
Odesa
Site reference ID 808
Ternopil
Site reference ID 817
Vinnytsia
Site reference ID 812
Zaporizhzhya
Site reference ID 815
Zaporizhzhya
Site reference ID 816
Zaporizhzhya
Bulgaria11 sites
Site reference ID 265
Gabrovo
Site reference ID 255
Pleven
Site reference ID 258
Plovdiv
Site reference ID 266
Sliven
Site reference ID 264
Smolyan
Site reference ID 251
Sofia
Site reference ID 252
Sofia
Site reference ID 254
Sofia
Site reference ID 256
Sofia
Site reference ID 257
Sofia
Site reference ID 267
Sofia
Czechia9 sites
Site reference ID 285
České Budějovice
Site reference ID 283
Písek
Site reference ID 281
Prague
Site reference ID 286
Prague
Site reference ID 287
Prague
Site reference ID 288
Prague
Site reference ID 284
Příbram
Site reference ID 289
Tábor
Site reference ID 282
Vsetín
Hungary9 sites
Site reference ID 315
Baja
Site reference ID 303
Budapest
Site reference ID 307
Budapest
Site reference ID 301
Debrecen
Site reference ID 308
Debrecen
Site reference ID 313
Debrecen
Site reference ID 314
Kecskemét
Site reference ID 304
Kistarcsa
Site reference ID 306
Nyíregyháza
Romania5 sites
Site reference ID 606
Brasov
Site reference ID 601
Bucharest
Site reference ID 603
Bucharest
Site reference ID 604
Bucharest
Site reference ID 605
Târgu Mureş
Lithuania4 sites
Site reference ID 463
Kaunas
Site reference ID 460
Vilnius
Site reference ID 461
Vilnius
Site reference ID 464
Vilnius
Latvia3 sites
Site reference ID 451
Riga
Site reference ID 452
Riga
Site reference ID 454
Riga
About this study
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
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.
Read the 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.
- Conditions
- Uterine Fibroids, Heavy Menstrual Bleeding
- Being tested
- OBE2109, Placebo to match OBE2109, Placebo to match Add-back, Add-back
- Keywords
- Uterine Fibroid, Leiomyomata, Heavy Menstrual Bleeding, HMB, Heavy Uterine Bleeding, Menorrhagia, OBE2109 + Add-back
- Medical subject headings
- Leiomyoma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBE2109Drug
OBE2109 100mg tablets for oral administration once daily
Placebo to match OBE2109Drug
Placebo to match OBE2109 100mg tablets for oral administration once daily
Placebo to match Add-backDrug
Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
Add-backDrug
Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
| Study group | Role | What they receive |
|---|---|---|
| OBE2109 dose 1 (100mg) + Placebo Add-back | Experimental | Not described Receives: Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Placebo to match Add-back |
| OBE2109 dose 1 (100mg) + Add-back | Experimental | Not described Receives: Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Add-back |
| OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back | Experimental | Not described Receives: Drug: OBE2109; Drug: Placebo to match Add-back; Drug: Add-back |
| OBE2109 dose 2 (200mg) + Add-back | Experimental | Not described Receives: Drug: OBE2109; Drug: Add-back |
| Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back | Placebo comparator | Not described Receives: Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Placebo to match Add-back; Drug: Add-back |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24
Assessed using the alkaline hematin method
Measured: From baseline to Week 24
Secondary outcomes (5)
Time to reduced menstrual blood loss
Assessed using the alkaline hematin method
Measured: Up to Week 52
Amenorrhea
Assessed using the alkaline hematin method
Measured: Up to Week 52
Time to amenorrhea
Measured: Up to Week 52
Number of days of uterine bleeding for the last 28-day interval prior to Week 24
Assessed using the alkaline hematin method
Measured: last 28-day interval prior to Week 24
Number of days of uterine bleeding for each 28-day interval
Assessed using the alkaline hematin method
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start23 May 2017
- Primary completion16 Sep 2019
- Study completion4 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- ObsEva SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ObsEva SA, Study director, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070951
- Sponsor's protocol ID
- 16-OBE2109-009
- Acronym
- PRIMROSE 2
- Status last verified
- Mar 2021
- First submitted
- 17 Feb 2017
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40543832Becker 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.
PubMed 40326221Donnez 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.
PubMed 36116480
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03070951
- Acronym / sponsor ID
- PRIMROSE 2 / 16-OBE2109-009
- Conditions
- Uterine Fibroids, Heavy Menstrual Bleeding
- Keywords
- Uterine Fibroid, Leiomyomata, Heavy Menstrual Bleeding, HMB, Heavy Uterine Bleeding, Menorrhagia, OBE2109 + Add-back
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- ObsEva SAIndustry (pharma, biotech, devices)
- Study start
- 23 May 2017 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 4 Oct 2020 (actual)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| OBE2109 dose 1 (100mg) + Placebo Add-back | Experimental | Drug: OBE2109, Drug: Placebo to match OBE2109, Drug: Placebo to match Add-back |
| OBE2109 dose 1 (100mg) + Add-back | Experimental | Drug: OBE2109, Drug: Placebo to match OBE2109, Drug: Add-back |
| OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back | Experimental | Drug: OBE2109, Drug: Placebo to match Add-back, Drug: Add-back |
| OBE2109 dose 2 (200mg) + Add-back | Experimental | Drug: OBE2109, Drug: Add-back |
| Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back | Placebo comparator | Drug: OBE2109, Drug: Placebo to match OBE2109, Drug: Placebo to match Add-back, Drug: Add-back |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBE2109OBE2109 100mg tablets for oral administration once daily | Drug | OBE2109 dose 1 (100mg) + Add-back, OBE2109 dose 1 (100mg) + Placebo Add-back, OBE2109 dose 2 (200mg) + Add-back, OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back, Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back |
| Placebo to match OBE2109Placebo to match OBE2109 100mg tablets for oral administration once daily | Drug | OBE2109 dose 1 (100mg) + Add-back, OBE2109 dose 1 (100mg) + Placebo Add-back, Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back |
| Placebo to match Add-backPlacebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily | Drug | OBE2109 dose 1 (100mg) + Placebo Add-back, OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back, Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back |
| Add-backAdd-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily | Drug | OBE2109 dose 1 (100mg) + Add-back, OBE2109 dose 2 (200mg) + Add-back, OBE2109 dose 2 (200mg) + Placebo Add-back / OBE2109 dose 2 (200 mg) + Add-back, Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-back |
Primary outcome
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
5 secondary outcomes
Time to reduced menstrual blood loss
Time frame: Up to Week 52
Amenorrhea
Time frame: Up to Week 52
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
Number of days of uterine bleeding for each 28-day interval
Time frame: Up to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Derived from this study: PubMed 40543832Donnez 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.
- Derived from this study: PubMed 40326221Becker 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.
- Derived from this study: PubMed 36116480Donnez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ObsEva SA study director
Geneva
96 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OBE2109 and Add-back in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by ObsEva SA at 96 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in United States, Poland, Ukraine, Bulgaria, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24 (time frame: From baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03070951, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.