Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

NCT03070899 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 16-OBE2109-008
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 116

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.

Conditions

Uterine Fibroids; Heavy Menstrual Bleeding

Keywords

Uterine Fibroid; Leiomyomata; Heavy Menstrual Bleeding; HMB; Heavy Uterine Bleeding; Menorrhagia; OBE2109 + Add-back

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24

  Assessed using the alkaline hematin method

  From baseline to Week 24

Secondary Outcomes (5)

• Time to reduced menstrual blood loss

  Up to Week 52

• Amenorrhea

  Up to Week 52

• Time to amenorrhea

  Up to Week 52

• Number of days of uterine bleeding for the last 28-day interval prior to Week 24

  last 28-day interval prior to Week 24

• Number of days of uterine bleeding for each 28-day interval

  Up to Week 52

Other Outcomes (3)

• Bone Mineral Density (BMD)

  From baseline up to Week 76

• Endometrial biopsy

  From baseline up to Week 52

• Adverse events

  Up to Week 76

Study Arms (5)

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

At W24, half of the patients switched to active treatment, while half remained on Placebo; the switch was defined at randomization.

Drug: OBE2109; Drug: Placebo to match OBE2109; Drug: Placebo to match Add-back; Drug: Add-back

Interventions

OBE2109 DRUG

OBE2109 100mg tablets for oral administration once daily

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 OBE2109 DRUG

Placebo to match OBE2109 100mg tablets for oral administration once daily

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-back DRUG

Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

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-back DRUG

Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ObsEva SA: lead

Study Sites (116)

Site reference ID 192

Birmingham, Alabama, 35205, United States

Location

Site reference ID 169

Dothan, Alabama, 33016, United States

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Site reference ID 353

Mobile, Alabama, 36608, United States

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Site reference ID 232

Vestavia Hills, Alabama, 35216, United States

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Site reference ID 242

Phoenix, Arizona, 85015, United States

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Site reference ID 355

Tucson, Arizona, 85712, United States

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Site reference ID 211

Arcadia, California, 91007, United States

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Site reference ID 184

Cerritos, California, 90703, United States

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Site reference ID 147

Escondido, California, 92866, United States

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Site reference ID 154

Huntington Park, California, 90255, United States

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Site reference ID 185

Los Angeles, California, 90255, United States

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Site reference ID 199

Northridge, California, 91324, United States

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Site reference ID 111

Panorama City, California, 91402, United States

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Site reference ID 166

Sacramento, California, 95821, United States

Location

Site reference ID 101

San Diego, California, 92108, United States

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Site reference ID 239

Upland, California, 91786, United States

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Site reference ID 112

Westminster, California, 92683, United States

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Site reference ID 144

Denver, Colorado, 80246, United States

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Site reference ID 246

Englewood, Colorado, 80112, United States

Location

Site reference ID 234

Thornton, Colorado, 80229, United States

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Site reference ID 189

New Haven, Connecticut, 06519, United States

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Site reference ID 105

Washington D.C., District of Columbia, 20036, United States

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Site reference ID 231

Boca Raton, Florida, 33433, United States

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Site reference ID 190

Boca Raton, Florida, 33486, United States

Location

Site reference ID 168

Clearwater, Florida, 33759, United States

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Site reference ID 233

DeLand, Florida, 32720, United States

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Site reference ID 197

Fort Lauderdale, Florida, 33316, United States

Location

Site reference ID 135

Hialeah, Florida, 33012, United States

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Site reference ID 146

Hialeah, Florida, 33012, United States

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Site reference ID 191

Jacksonville, Florida, 32256, United States

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Site reference ID 204

Loxahatchee Groves, Florida, 33470, United States

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Site reference ID 137

Miami, Florida, 33130, United States

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Site reference ID 142

Miami, Florida, 33144, United States

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Site reference ID 110

Miami, Florida, 33165, United States

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Site reference ID 106

Miami, Florida, 33176, United States

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Site reference ID 127

Miami, Florida, 33176, United States

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Site reference ID 117

Miami Lakes, Florida, 33016, United States

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Site reference ID 134

Miami Lakes, Florida, 33016, United States

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Site reference ID 129

Miami Springs, Florida, 33166, United States

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Site reference ID 107

Miramar, Florida, 33027, United States

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Site reference ID 124

New Port Richey, Florida, 34653, United States

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Site reference ID 141

Orlando, Florida, 32801, United States

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Site reference ID 140

Orlando, Florida, 32806, United States

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Site reference ID 207

St. Petersburg, Florida, 33709, United States

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Site reference ID 113

Tampa, Florida, 33613, United States

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Site reference ID 163

Columbus, Georgia, 31904, United States

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Site reference ID 158

Norcross, Georgia, 30092, United States

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Site reference ID 151

Norcross, Georgia, 30093, United States

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Site reference ID 150

Sandy Springs, Georgia, 30328, United States

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Site reference ID 359

Idaho Falls, Idaho, 83404, United States

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Site reference ID 352

Meridian, Idaho, 83642, United States

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Site reference ID 174

Champaign, Illinois, 61820, United States

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Site reference ID 182

Oak Brook, Illinois, 60523, United States

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Site reference ID 178

Shawnee Mission, Kansas, 66218, United States

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Site reference ID 354

Wichita, Kansas, 67207, United States

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Site reference ID 176

Lake Charles, Louisiana, 70601, United States

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Site reference ID 109

Marrero, Louisiana, 70072, United States

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Site reference ID 248

Frederick, Maryland, 21702, United States

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Site reference ID 226

Silver Spring, Maryland, 20910, United States

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Site reference ID 228

Towson, Maryland, 21204, United States

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Site reference ID 149

Fall River, Massachusetts, 02720, United States

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Site reference ID 126

Fall River, Massachusetts, 02721, United States

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Site reference ID 100

Bay City, Michigan, 48706, United States

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Site reference ID 145

Detroit, Michigan, 48034, United States

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Site reference ID 214

Saginaw, Michigan, 48602, United States

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Site reference ID 170

Saginaw, Michigan, 48604, United States

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Site reference ID 138

Missoula, Montana, 59808, United States

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Site reference ID 236

Las Vegas, Nevada, 89109, United States

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Site reference ID 245

Lawrenceville, New Jersey, 08648, United States

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Site reference ID 175

Brooklyn, New York, 11203, United States

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Site reference ID 188

New York, New York, 10016, United States

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Site reference ID 208

Port Jefferson, New York, 11764, United States

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Site reference ID 133

Staten Island, New York, 10306, United States

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Site reference ID 104

Greensboro, North Carolina, 27408, United States

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Site reference ID 131

Morehead City, North Carolina, 28557, United States

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Site reference ID 102

Raleigh, North Carolina, 27607, United States

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Site reference ID 187

Southern Pines, North Carolina, 28374, United States

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Site reference ID 119

Winston-Salem, North Carolina, 27103, United States

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Site reference ID 186

Cincinnati, Ohio, 45212, United States

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Site reference ID 164

Cleveland, Ohio, 44122, United States

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Site reference ID 230

Fairfield, Ohio, 45014, United States

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Site reference ID 213

Franklin, Ohio, 45005, United States

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Site reference ID 116

Bryn Mawr, Pennsylvania, 19010, United States

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Site reference ID 195

Hershey, Pennsylvania, 17033, United States

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Site reference ID 222

Indiana, Pennsylvania, 15701, United States

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Site reference ID 165

Jenkintown, Pennsylvania, 19046, United States

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Site reference ID 210

Pittsburgh, Pennsylvania, 15243, United States

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Site reference ID 148

Smithfield, Pennsylvania, 15478, United States

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Site reference ID 351

North Charleston, South Carolina, 29406, United States

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Site reference ID 358

Spartanburg, South Carolina, 29301, United States

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Site reference ID 159

Chattanooga, Tennessee, 37404, United States

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Site reference ID 235

Knoxville, Tennessee, 37920, United States

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Site reference ID 205

Memphis, Tennessee, 38119, United States

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Site reference ID 180

Memphis, Tennessee, 38120, United States

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Site reference ID 238

Austin, Texas, 78726, United States

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Site reference ID 155

Austin, Texas, 78758, United States

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Site reference ID 201

Beaumont, Texas, 77702, United States

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Site reference ID 247

Corpus Christi, Texas, 78412, United States

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Site reference ID 183

Dallas, Texas, 75231, United States

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Site reference ID 216

Dallas, Texas, 75231, United States

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Site reference ID 200

Dallas, Texas, 75234, United States

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Site reference ID 250

Fort Worth, Texas, 76104, United States

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Site reference ID 244

Fort Worth, Texas, 76132, United States

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Site reference ID 115

Frisco, Texas, 75035, United States

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Site reference ID 157

Houston, Texas, 77030, United States

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Site reference ID 120

Houston, Texas, 77054, United States

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Site reference ID 219

Houston, Texas, 77071, United States

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Site reference ID 217

Houston, Texas, 77074, United States

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Site reference ID 218

Pasadena, Texas, 77505, United States

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Site reference ID 172

San Antonio, Texas, 78258, United States

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Site reference ID 128

Webster, Texas, 77598, United States

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Site reference ID 125

West Jordan, Utah, 84088, United States

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Site reference ID 103

Norfolk, Virginia, 23507, United States

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Site reference ID 171

Norfolk, Virginia, 23507, United States

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Site reference ID 123

Richmond, Virginia, 23233, United States

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Site reference ID 237

Bellevue, Washington, 98007, United States

Location

Related Publications (3)

• 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.

  PMID: 40543832 DERIVED

• 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.

  PMID: 40326221 DERIVED

• 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.

  PMID: 36116480 DERIVED

MeSH Terms

Conditions

Leiomyoma; Menorrhagia

Interventions

linzagolix

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• ObsEva SA

  Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: March 6, 2017
• Study Start: April 20, 2017
• Primary Completion: April 14, 2020
• Study Completion: April 12, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

US (116)