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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 : April 16, 2019
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.


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

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Locations
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United States, Alabama
Site reference ID 192 Recruiting
Birmingham, Alabama, United States, 35205
Site reference ID 169 Recruiting
Dothan, Alabama, United States, 33016
Site reference ID 353 Recruiting
Mobile, Alabama, United States, 36608
Site reference ID 232 Recruiting
Vestavia Hills, Alabama, United States, 35216
United States, Arizona
Site reference ID 242 Recruiting
Phoenix, Arizona, United States, 85015
Site reference ID 355 Recruiting
Tucson, Arizona, United States, 85712
United States, California
Site reference ID 211 Recruiting
Arcadia, California, United States, 91007
Site reference ID 184 Recruiting
Cerritos, California, United States, 90703
Site reference ID 167 Withdrawn
Corona, California, United States, 92879
Site reference ID 147 Recruiting
Escondido, California, United States, 92866
Site reference ID 154 Recruiting
Huntington Park, California, United States, 90255
Site reference ID 185 Recruiting
Los Angeles, California, United States, 90255
Site reference ID 199 Recruiting
Northridge, California, United States, 91324
Site reference ID 111 Recruiting
Panorama City, California, United States, 91402
Site reference ID 166 Recruiting
Sacramento, California, United States, 95821
Site reference ID 101 Recruiting
San Diego, California, United States, 92108
Site reference ID 243 Recruiting
San Marcos, California, United States, 92078
Site reference ID 239 Recruiting
Upland, California, United States, 91786
Site reference ID 112 Recruiting
Westminster, California, United States, 92683
United States, Colorado
Site reference ID 144 Recruiting
Denver, Colorado, United States, 80246
Site reference ID 246 Recruiting
Englewood, Colorado, United States, 80112
Site reference ID 234 Recruiting
Thornton, Colorado, United States, 80229
United States, Connecticut
Site reference ID 189 Recruiting
New Haven, Connecticut, United States, 06519
United States, District of Columbia
Site reference ID 105 Recruiting
Washington, District of Columbia, United States, 20036
United States, Florida
Site reference ID 231 Recruiting
Boca Raton, Florida, United States, 33433
Site reference ID 190 Recruiting
Boca Raton, Florida, United States, 33486
Site reference ID 168 Recruiting
Clearwater, Florida, United States, 33759
Site reference ID 233 Recruiting
DeLand, Florida, United States, 32720
Site reference ID 197 Recruiting
Fort Lauderdale, Florida, United States, 33316
Site reference ID 118 Withdrawn
Gainesville, Florida, United States, 32605
Site reference ID 135 Recruiting
Hialeah, Florida, United States, 33012
Site reference ID 146 Recruiting
Hialeah, Florida, United States, 33012
Site reference ID 139 Terminated
Homestead, Florida, United States, 33030
Site reference ID 191 Recruiting
Jacksonville, Florida, United States, 32256
Site reference ID 204 Recruiting
Loxahatchee Groves, Florida, United States, 33470
Site reference ID 117 Recruiting
Miami Lakes, Florida, United States, 33016
Site reference ID 134 Recruiting
Miami Lakes, Florida, United States, 33016
Site reference ID 129 Recruiting
Miami Springs, Florida, United States, 33166
Site reference ID 137 Recruiting
Miami, Florida, United States, 33130
Site reference ID 142 Recruiting
Miami, Florida, United States, 33144
Site reference ID 110 Recruiting
Miami, Florida, United States, 33165
Site reference ID 106 Recruiting
Miami, Florida, United States, 33176
Site reference ID 127 Recruiting
Miami, Florida, United States, 33176
Site reference ID 107 Recruiting
Miramar, Florida, United States, 33027
Site reference ID 124 Recruiting
New Port Richey, Florida, United States, 34653
Site reference ID 141 Recruiting
Orlando, Florida, United States, 32801
Site reference ID 140 Recruiting
Orlando, Florida, United States, 32806
Site reference ID 132 Withdrawn
Panama City, Florida, United States, 32405
Site reference ID 207 Recruiting
Saint Petersburg, Florida, United States, 33709
Site reference ID 113 Recruiting
Tampa, Florida, United States, 33613
Site reference ID 114 Withdrawn
Wellington, Florida, United States, 33414
United States, Georgia
Site reference ID 163 Recruiting
Columbus, Georgia, United States, 31904
Site reference ID 158 Recruiting
Norcross, Georgia, United States, 30092
Site reference ID 151 Recruiting
Norcross, Georgia, United States, 30093
Site reference ID 150 Recruiting
Sandy Springs, Georgia, United States, 30328
Site reference ID 215 Withdrawn
Suwanee, Georgia, United States, 30024
United States, Idaho
Site reference ID 359 Recruiting
Idaho Falls, Idaho, United States, 83404
Site reference ID 352 Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
Site reference ID 174 Recruiting
Champaign, Illinois, United States, 61820
Site reference ID 240 Recruiting
Decatur, Illinois, United States, 62526
Site reference ID 182 Recruiting
Oak Brook, Illinois, United States, 60523
United States, Kansas
Site reference ID 178 Recruiting
Shawnee Mission, Kansas, United States, 66218
Site reference ID 354 Recruiting
Wichita, Kansas, United States, 67207
United States, Louisiana
Site reference ID 176 Recruiting
Lake Charles, Louisiana, United States, 70601
Site reference ID 109 Recruiting
Marrero, Louisiana, United States, 70072
United States, Maryland
Site reference ID 248 Recruiting
Frederick, Maryland, United States, 21702
Site reference ID 224 Withdrawn
Gaithersburg, Maryland, United States, 20878
Site reference ID 226 Recruiting
Silver Spring, Maryland, United States, 20910
Site reference ID 228 Recruiting
Towson, Maryland, United States, 21204
United States, Massachusetts
Site reference ID 149 Recruiting
Fall River, Massachusetts, United States, 02720
Site reference ID 126 Recruiting
Fall River, Massachusetts, United States, 02721
United States, Michigan
Site reference ID 100 Recruiting
Bay City, Michigan, United States, 48706
Site reference ID 145 Recruiting
Detroit, Michigan, United States, 48034
Site reference ID 214 Recruiting
Saginaw, Michigan, United States, 48602
Site reference ID 170 Recruiting
Saginaw, Michigan, United States, 48604
United States, Montana
Site reference ID 138 Recruiting
Missoula, Montana, United States, 59808
United States, Nevada
Site reference ID 236 Recruiting
Las Vegas, Nevada, United States, 89109
Site reference ID 136 Withdrawn
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Site reference ID 245 Recruiting
Lawrenceville, New Jersey, United States, 08648
United States, New York
Site reference ID 175 Recruiting
Brooklyn, New York, United States, 11203
Site reference ID 188 Recruiting
New York, New York, United States, 10016
Site reference ID 208 Recruiting
Port Jefferson, New York, United States, 11764
Site reference ID 133 Recruiting
Staten Island, New York, United States, 10306
United States, North Carolina
Site reference ID 104 Recruiting
Greensboro, North Carolina, United States, 27408
Site reference ID 130 Withdrawn
Hickory, North Carolina, United States, 28602
Site reference ID 131 Recruiting
Morehead City, North Carolina, United States, 28557
Site reference ID 102 Recruiting
Raleigh, North Carolina, United States, 27607
Site reference ID 187 Recruiting
Southern Pines, North Carolina, United States, 28374
Site reference ID 119 Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Site reference ID 186 Recruiting
Cincinnati, Ohio, United States, 45212
Site reference ID 164 Recruiting
Cleveland, Ohio, United States, 44122
Site reference ID 230 Recruiting
Fairfield, Ohio, United States, 45014
Site reference ID 213 Recruiting
Franklin, Ohio, United States, 45005
United States, Pennsylvania
Site reference ID 116 Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Site reference ID 195 Recruiting
Hershey, Pennsylvania, United States, 17033
Site reference ID 222 Recruiting
Indiana, Pennsylvania, United States, 15701
Site reference ID 165 Recruiting
Jenkintown, Pennsylvania, United States, 19046
Site reference ID 210 Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Site reference ID 148 Recruiting
Smithfield, Pennsylvania, United States, 15478
United States, South Carolina
Site reference ID 209 Recruiting
Greenville, South Carolina, United States, 29615
Site reference ID 351 Recruiting
North Charleston, South Carolina, United States, 29406
Site reference ID 358 Recruiting
Spartanburg, South Carolina, United States, 29301
United States, Tennessee
Site reference ID 159 Recruiting
Chattanooga, Tennessee, United States, 37404
Site reference ID 235 Recruiting
Knoxville, Tennessee, United States, 37920
Site reference ID 205 Recruiting
Memphis, Tennessee, United States, 38119
Site reference ID 180 Recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
Site reference ID 238 Recruiting
Austin, Texas, United States, 78726
Site reference ID 155 Recruiting
Austin, Texas, United States, 78758
Site reference ID 201 Recruiting
Beaumont, Texas, United States, 77702
Site reference ID 247 Recruiting
Corpus Christi, Texas, United States, 78412
Site reference ID 183 Recruiting
Dallas, Texas, United States, 75231
Site reference ID 216 Recruiting
Dallas, Texas, United States, 75231
Site reference ID 200 Recruiting
Dallas, Texas, United States, 75234
Site reference ID 357 Recruiting
Edinburg, Texas, United States, 78539
Site reference ID 250 Recruiting
Fort Worth, Texas, United States, 76104
Site reference ID 244 Recruiting
Fort Worth, Texas, United States, 76132
Site reference ID 115 Recruiting
Frisco, Texas, United States, 75035
Site reference ID 157 Recruiting
Houston, Texas, United States, 77030
Site reference ID 120 Recruiting
Houston, Texas, United States, 77054
Site reference ID 219 Recruiting
Houston, Texas, United States, 77071
Site reference ID 217 Recruiting
Houston, Texas, United States, 77074
Site reference ID 198 Recruiting
Houston, Texas, United States, 77084
Site reference ID 218 Recruiting
Pasadena, Texas, United States, 77505
Site reference ID 172 Recruiting
San Antonio, Texas, United States, 78258
Site reference ID 128 Recruiting
Webster, Texas, United States, 77598
United States, Utah
Site reference ID 125 Recruiting
West Jordan, Utah, United States, 84088
United States, Virginia
Site reference ID 162 Withdrawn
Centreville, Virginia, United States, 20121
Site reference ID 103 Recruiting
Norfolk, Virginia, United States, 23507
Site reference ID 171 Recruiting
Norfolk, Virginia, United States, 23507
Site reference ID 123 Recruiting
Richmond, Virginia, United States, 23233
United States, Washington
Site reference ID 237 Recruiting
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
ObsEva SA
Investigators
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Study Director: ObsEva SA Geneva

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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: April 16, 2019
Last Verified: October 2018

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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:
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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
Menstruation Disturbances
OBE2109
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs