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Uterine FibroidsPhase 3PRIMROSE 1NCT03070899

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 116 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
526 participants
Where
116 sitesUnited States
Study dates
20 Apr 2017to 12 Apr 2021
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

116 sites in 1 country.

116 sites in 1 country

United States116 sites

  • Site reference ID 211

    Arcadia, California, 91007

  • Site reference ID 238

    Austin, Texas, 78726

  • Site reference ID 155

    Austin, Texas, 78758

  • Site reference ID 100

    Bay City, Michigan, 48706

  • Site reference ID 201

    Beaumont, Texas, 77702

  • Site reference ID 237

    Bellevue, Washington, 98007

  • Site reference ID 192

    Birmingham, Alabama, 35205

  • Site reference ID 231

    Boca Raton, Florida, 33433

  • Site reference ID 190

    Boca Raton, Florida, 33486

  • Site reference ID 175

    Brooklyn, New York, 11203

  • Site reference ID 116

    Bryn Mawr, Pennsylvania, 19010

  • Site reference ID 184

    Cerritos, California, 90703

  • Site reference ID 174

    Champaign, Illinois, 61820

  • Site reference ID 159

    Chattanooga, Tennessee, 37404

  • Site reference ID 186

    Cincinnati, Ohio, 45212

  • Site reference ID 168

    Clearwater, Florida, 33759

  • Site reference ID 164

    Cleveland, Ohio, 44122

  • Site reference ID 163

    Columbus, Georgia, 31904

  • Site reference ID 247

    Corpus Christi, Texas, 78412

  • Site reference ID 183

    Dallas, Texas, 75231

  • Site reference ID 216

    Dallas, Texas, 75231

  • Site reference ID 200

    Dallas, Texas, 75234

  • Site reference ID 233

    DeLand, Florida, 32720

  • Site reference ID 144

    Denver, Colorado, 80246

  • Site reference ID 145

    Detroit, Michigan, 48034

  • Site reference ID 169

    Dothan, Alabama, 33016

  • Site reference ID 246

    Englewood, Colorado, 80112

  • Site reference ID 147

    Escondido, California, 92866

  • Site reference ID 230

    Fairfield, Ohio, 45014

  • Site reference ID 149

    Fall River, Massachusetts, 02720

  • Site reference ID 126

    Fall River, Massachusetts, 02721

  • Site reference ID 197

    Fort Lauderdale, Florida, 33316

  • Site reference ID 250

    Fort Worth, Texas, 76104

  • Site reference ID 244

    Fort Worth, Texas, 76132

  • Site reference ID 213

    Franklin, Ohio, 45005

  • Site reference ID 248

    Frederick, Maryland, 21702

  • Site reference ID 115

    Frisco, Texas, 75035

  • Site reference ID 104

    Greensboro, North Carolina, 27408

  • Site reference ID 195

    Hershey, Pennsylvania, 17033

  • Site reference ID 135

    Hialeah, Florida, 33012

  • Site reference ID 146

    Hialeah, Florida, 33012

  • Site reference ID 157

    Houston, Texas, 77030

  • Site reference ID 120

    Houston, Texas, 77054

  • Site reference ID 219

    Houston, Texas, 77071

  • Site reference ID 217

    Houston, Texas, 77074

  • Site reference ID 154

    Huntington Park, California, 90255

  • Site reference ID 359

    Idaho Falls, Idaho, 83404

  • Site reference ID 222

    Indiana, Pennsylvania, 15701

  • Site reference ID 191

    Jacksonville, Florida, 32256

  • Site reference ID 165

    Jenkintown, Pennsylvania, 19046

  • Site reference ID 235

    Knoxville, Tennessee, 37920

  • Site reference ID 176

    Lake Charles, Louisiana, 70601

  • Site reference ID 236

    Las Vegas, Nevada, 89109

  • Site reference ID 245

    Lawrenceville, New Jersey, 08648

  • Site reference ID 185

    Los Angeles, California, 90255

  • Site reference ID 204

    Loxahatchee Groves, Florida, 33470

  • Site reference ID 109

    Marrero, Louisiana, 70072

  • Site reference ID 205

    Memphis, Tennessee, 38119

  • Site reference ID 180

    Memphis, Tennessee, 38120

  • Site reference ID 352

    Meridian, Idaho, 83642

  • Site reference ID 137

    Miami, Florida, 33130

  • Site reference ID 142

    Miami, Florida, 33144

  • Site reference ID 110

    Miami, Florida, 33165

  • Site reference ID 106

    Miami, Florida, 33176

  • Site reference ID 127

    Miami, Florida, 33176

  • Site reference ID 117

    Miami Lakes, Florida, 33016

  • Site reference ID 134

    Miami Lakes, Florida, 33016

  • Site reference ID 129

    Miami Springs, Florida, 33166

  • Site reference ID 107

    Miramar, Florida, 33027

  • Site reference ID 138

    Missoula, Montana, 59808

  • Site reference ID 353

    Mobile, Alabama, 36608

  • Site reference ID 131

    Morehead City, North Carolina, 28557

  • Site reference ID 189

    New Haven, Connecticut, 06519

  • Site reference ID 124

    New Port Richey, Florida, 34653

  • Site reference ID 188

    New York, New York, 10016

  • Site reference ID 158

    Norcross, Georgia, 30092

  • Site reference ID 151

    Norcross, Georgia, 30093

  • Site reference ID 103

    Norfolk, Virginia, 23507

  • Site reference ID 171

    Norfolk, Virginia, 23507

  • Site reference ID 351

    North Charleston, South Carolina, 29406

  • Site reference ID 199

    Northridge, California, 91324

  • Site reference ID 182

    Oak Brook, Illinois, 60523

  • Site reference ID 141

    Orlando, Florida, 32801

  • Site reference ID 140

    Orlando, Florida, 32806

  • Site reference ID 111

    Panorama City, California, 91402

  • Site reference ID 218

    Pasadena, Texas, 77505

  • Site reference ID 242

    Phoenix, Arizona, 85015

  • Site reference ID 210

    Pittsburgh, Pennsylvania, 15243

  • Site reference ID 208

    Port Jefferson, New York, 11764

  • Site reference ID 102

    Raleigh, North Carolina, 27607

  • Site reference ID 123

    Richmond, Virginia, 23233

  • Site reference ID 166

    Sacramento, California, 95821

  • Site reference ID 214

    Saginaw, Michigan, 48602

  • Site reference ID 170

    Saginaw, Michigan, 48604

  • Site reference ID 172

    San Antonio, Texas, 78258

  • Site reference ID 101

    San Diego, California, 92108

  • Site reference ID 150

    Sandy Springs, Georgia, 30328

  • Site reference ID 178

    Shawnee Mission, Kansas, 66218

  • Site reference ID 226

    Silver Spring, Maryland, 20910

  • Site reference ID 148

    Smithfield, Pennsylvania, 15478

  • Site reference ID 187

    Southern Pines, North Carolina, 28374

  • Site reference ID 358

    Spartanburg, South Carolina, 29301

  • Site reference ID 207

    St. Petersburg, Florida, 33709

  • Site reference ID 133

    Staten Island, New York, 10306

  • Site reference ID 113

    Tampa, Florida, 33613

  • Site reference ID 234

    Thornton, Colorado, 80229

  • Site reference ID 228

    Towson, Maryland, 21204

  • Site reference ID 355

    Tucson, Arizona, 85712

  • Site reference ID 239

    Upland, California, 91786

  • Site reference ID 232

    Vestavia Hills, Alabama, 35216

  • Site reference ID 105

    Washington D.C., District of Columbia, 20036

  • Site reference ID 128

    Webster, Texas, 77598

  • Site reference ID 125

    West Jordan, Utah, 84088

  • Site reference ID 112

    Westminster, California, 92683

  • Site reference ID 354

    Wichita, Kansas, 67207

  • Site reference ID 119

    Winston-Salem, North Carolina, 27103

Other trials in United States

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.

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 groups in NCT03070899
Study groupRoleWhat they receive
OBE2109 dose 1 (100mg) + Placebo Add-backExperimentalNot described
Receives: Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Placebo to match Add-back
OBE2109 dose 1 (100mg) + Add-backExperimentalNot 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-backExperimentalNot described
Receives: Drug: OBE2109; Drug: Placebo to match Add-back; Drug: Add-back
OBE2109 dose 2 (200mg) + Add-backExperimentalNot described
Receives: Drug: OBE2109; Drug: Add-back
Placebo + Placebo Add-back / OBE2109 dose 3 (200mg) + Add-backPlacebo comparatorAt W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.
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.

  1. 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)

  1. Time to reduced menstrual blood loss

    Assessed using the alkaline hematin method

    Measured: Up to Week 52

  2. Amenorrhea

    Assessed using the alkaline hematin method

    Measured: Up to Week 52

  3. Time to amenorrhea

    Measured: Up to Week 52

  4. 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

  5. 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.

  1. First posted6 Mar 2017
  2. Study start20 Apr 2017
  3. Primary completion14 Apr 2020
  4. Study completion12 Apr 2021

Resources

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
526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03070899
Sponsor's protocol ID
16-OBE2109-008
Acronym
PRIMROSE 1
Status last verified
Jun 2021
First submitted
17 Feb 2017
Last updated
9 Jun 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 40543832

  • Becker 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 40326221

  • Donnez 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

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 116 sites in United States.

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 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States. 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 NCT03070899, 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 9 Jun 2021.

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