A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
- Conditions
- Endometriosis
- Interventions
- Drug: Placebo for E2/NETA
- Registration Number
- NCT03213457
- Lead Sponsor
- AbbVie
- Brief Summary
The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 681
-
Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.
-
Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization within 10 years prior to entry into Washout or Screening.
-
Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
-
Participant must have the following documented in the e-Diary during the last 35 days prior to Study Day 1:
- At least 2 days of "moderate" or "severe" dysmenorrhea (DYS) AND either
- At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (NMPP) and an average NMPP score of at least 1.0, OR
- At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.
-
Participant has chronic pelvic pain that is not caused by endometriosis, that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-related pain.
-
Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled or intranasal corticosteroids are allowed.
-
Participant has a history of any major depression or post-traumatic stress disorder (PTSD) within 2 years of the screening visit or other major psychiatric disorder at any time.
-
Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the last 1 year at Screening or prior to randomization on Day 1.
-
Participant has any history of osteoporosis or other metabolic bone disease or any condition that would interfere with obtaining adequate dual energy x-ray absorptiometry (DXA) measurements
-
Screening DXA results of the lumbar spine (L1-L4), femoral neck or total hip bone mineral density (BMD) corresponding to less than 2.0 or more standard deviations below normal.
-
Participant has either:
- a newly diagnosed, clinically significant medical condition that requires therapeutic intervention (e.g., new onset hypertension), that has not been stabilized 30 days prior to randomization on Day 1 OR
- a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR
- an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the Investigator, (including, but not limited to, uncontrolled diabetes mellitus, uncontrolled hypertension, epilepsy requiring anti-epileptic medication, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).
-
Participant has any conditions contraindicated with use of E2/NETA.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elagolix / Elagolix + E2/NETA Estradiol/Norethindrone Acetate Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. Elagolix + E2/NETA Estradiol/Norethindrone Acetate Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. Placebo Placebo for Elagolix Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. Elagolix / Elagolix + E2/NETA Elagolix Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. Placebo Placebo for E2/NETA Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period. Elagolix + E2/NETA Elagolix Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
- Primary Outcome Measures
Name Time Method Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment Month 6, Month 12 Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
* 0: No discomfort
* 1: Mild discomfort but I was easily able to do the things I usually do
* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
* 3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over 35 days prior to each visit.
Response was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesic).Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment Month 6, Month 12 Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
* 0: No discomfort
* 1: Mild discomfort but I was easily able to do the things I usually do
* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
* 3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Response was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics).
- Secondary Outcome Measures
Name Time Method Change From Baseline in NMPP at Month 6 Based on Daily Assessment Baseline, Month 6 Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
* 0: No discomfort
* 1: Mild discomfort but I was easily able to do the things I usually do
* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
* 3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment Baseline, Month 12 Participants assessed DYSP each day in an e-Diary according to the following response options:
* 0: None; No discomfort during sexual intercourse
* 1: Mild; Able to tolerate the discomfort during sexual intercourse
* 2: Moderate; Intercourse was interrupted due to pain
* 3: Severe; Avoided intercourse because of pain
* Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.
Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.Change From Baseline in DYSP at Month 3 Based on Daily Assessment Baseline, Month 3 Participants assessed DYSP each day in an e-Diary according to the following response options:
* 0: None; No discomfort during sexual intercourse
* 1: Mild; Able to tolerate the discomfort during sexual intercourse
* 2: Moderate; Intercourse was interrupted due to pain
* 3: Severe; Avoided intercourse because of pain
* Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.
Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.Change From Baseline in NMPP at Month 3 Based on Daily Assessment Baseline, Month 3 Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
* 0: No discomfort
* 1: Mild discomfort but I was easily able to do the things I usually do
* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
* 3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS) Baseline, Month 12 The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS Baseline, Month 3 The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score Baseline, Month 12 The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.
Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS Baseline, Month 6 The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score Baseline, Month 6 The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.
Change From Baseline in DYS at Month 12 Based on Daily Assessment Baseline, Month 12 Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
* 0: No discomfort
* 1: Mild discomfort but I was easily able to do the things I usually do
* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
* 3: Severe pain that made it difficult to do the things I usually do.
Pain scores were averaged over the 35 days prior to each visit.Change From Baseline in DYS at Month 6 Based on Daily Assessment Baseline, Month 6 Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1. Mild discomfort but I was easily able to do the things I usually do
2. Moderate discomfort or pain that made it difficult to do some of the things I usually do
3. Severe pain that made it difficult to do the things I usually do.
Pain scores were averaged over the 35 days prior to each visit.Change From Baseline in DYS at Month 3 Based on Daily Assessment Baseline, Month 3 Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1. Mild discomfort but I was easily able to do the things I usually do
2. Moderate discomfort or pain that made it difficult to do some of the things I usually do
3. Severe pain that made it difficult to do the things I usually do.
Pain scores were averaged over the 35 days prior to each visit.Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment Baseline, Month 12 Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
* 0: No discomfort
* 1: Mild discomfort but I was easily able to do the things I usually do
* 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
* 3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.Change From Baseline in DYSP at Month 6 Based on Daily Assessment Baseline, Month 6 Participants assessed DYSP each day in an e-Diary according to the following response options:
* 0: None; No discomfort during sexual intercourse
* 1: Mild; Able to tolerate the discomfort during sexual intercourse
* 2: Moderate; Intercourse was interrupted due to pain
* 3: Severe; Avoided intercourse because of pain
* Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.
Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Trial Locations
- Locations (197)
Clinical Research Adv, Inc. /ID# 149257
🇺🇸Puyallup, Washington, United States
Tidewater Clinical Research /ID# 145397
🇺🇸Virginia Beach, Virginia, United States
Atlanta Women's Research Inst /ID# 145543
🇺🇸Atlanta, Georgia, United States
James A. Simon, MD, PC /ID# 145480
🇺🇸Washington, District of Columbia, United States
Southern Women's Specialists PC /ID# 148750
🇺🇸Fairhope, Alabama, United States
Arizona Research Assoc /ID# 161703
🇺🇸Tucson, Arizona, United States
Glendale Adventist Medical Ctr /ID# 160530
🇺🇸Glendale, California, United States
Red Rocks OB/GYN /ID# 145325
🇺🇸Lakewood, Colorado, United States
Long Beach Clinical Trial Serv /ID# 152428
🇺🇸Long Beach, California, United States
University of South Alabama /ID# 148774
🇺🇸Mobile, Alabama, United States
Unity Health- Searcy Medical Center /ID# 203674
🇺🇸Searcy, Arkansas, United States
Eclipse Clinical Research /ID# 155600
🇺🇸Tucson, Arizona, United States
Core Healthcare Group /ID# 149321
🇺🇸Cerritos, California, United States
Women's Health Alliance of Mobile /ID# 150083
🇺🇸Mobile, Alabama, United States
Omega Research Maitland, LLC /ID# 145167
🇺🇸DeBary, Florida, United States
HRC Fertility /ID# 154143
🇺🇸Encino, California, United States
Mesa Obstetricians and Gynecologists /ID# 147320
🇺🇸Mesa, Arizona, United States
HCP Clinical Research LLC /ID# 152045
🇺🇸Huntington Beach, California, United States
Univ Maryland School Medicine /ID# 151739
🇺🇸Baltimore, Maryland, United States
Eastern Maine Medical Center /ID# 161681
🇺🇸Bangor, Maine, United States
Alta California Medical Group /ID# 155706
🇺🇸Simi Valley, California, United States
Paramount Research Solutions /ID# 149320
🇺🇸Alpharetta, Georgia, United States
Huntington Medical Foundation /ID# 154750
🇺🇸Pasadena, California, United States
Gulf Coast Research Group /ID# 162895
🇺🇸Brandon, Florida, United States
Vista Health Research LLC - Miami /ID# 151455
🇺🇸Miami, Florida, United States
Vida Clinical Research /ID# 150282
🇺🇸Kissimmee, Florida, United States
Baltimore Suburban Health /ID# 147164
🇺🇸Baltimore, Maryland, United States
Jersey Shore University Medical Center /ID# 148756
🇺🇸Neptune, New Jersey, United States
Olympian Clinical Research /ID# 148167
🇺🇸Clearwater, Florida, United States
Sonora Clinical Research /ID# 145541
🇺🇸Meridian, Idaho, United States
Asr, Llc /Id# 161680
🇺🇸Nampa, Idaho, United States
Rutgers Robert Wood Johnson /ID# 152858
🇺🇸New Brunswick, New Jersey, United States
Womens Healthcare Assoc, DBA /ID# 148744
🇺🇸Idaho Falls, Idaho, United States
Axcess Medical Center /ID# 148169
🇺🇸Loxahatchee Groves, Florida, United States
Precision Research Organization /ID# 145337
🇺🇸Miami Lakes, Florida, United States
DJL Clinical Research, PLLC /ID# 154679
🇺🇸Charlotte, North Carolina, United States
Advanced Clinical Research /ID# 147086
🇺🇸Meridian, Idaho, United States
Horizon Research Group /ID# 148171
🇺🇸Eunice, Louisiana, United States
OB.GYN Associates of WNY /ID# 161665
🇺🇸West Seneca, New York, United States
Great Lakes Research Group, Inc. /ID# 145308
🇺🇸Bay City, Michigan, United States
Praetorian Pharmaceutical Res /ID# 145405
🇺🇸Marrero, Louisiana, United States
OB/GYN Associates of Erie /ID# 157935
🇺🇸Erie, Pennsylvania, United States
Manhattan Medical Research /ID# 145175
🇺🇸New York, New York, United States
Columbia Univ Medical Center /ID# 145334
🇺🇸New York, New York, United States
Prism Research /ID# 159751
🇺🇸Saint Paul, Minnesota, United States
Women's Health Clinic /ID# 155707
🇺🇸Shreveport, Louisiana, United States
Clinical Trials Management, LLC - Covington /ID# 145520
🇺🇸Covington, Louisiana, United States
NECCR Fall River LLC /ID# 145329
🇺🇸Fall River, Massachusetts, United States
Pinewest Ob-Gyn, Inc. /ID# 151743
🇺🇸High Point, North Carolina, United States
SUNY Downstate Medical Center /ID# 148749
🇺🇸Brooklyn, New York, United States
James T. Martin, Jr., MD., Obs /ID# 148755
🇺🇸North Charleston, South Carolina, United States
Saginaw Valley Med Res Group /ID# 145527
🇺🇸Saginaw, Michigan, United States
St. Joseph's Regional Medical /ID# 157759
🇺🇸Totowa, New Jersey, United States
Unified Women's Clinical Resea /ID# 145353
🇺🇸Raleigh, North Carolina, United States
Womens Clinic of Lincoln, P.C. /ID# 145366
🇺🇸Lincoln, Nebraska, United States
Mount Sinai Hosp.-Toronto /ID# 148972
🇨🇦Toronto, Ontario, Canada
PMG Research of Charlotte /ID# 145432
🇺🇸Charlotte, North Carolina, United States
Research Memphis Associates, LLC /ID# 150100
🇺🇸Memphis, Tennessee, United States
Univ Hosp Cleveland /ID# 148741
🇺🇸Cleveland, Ohio, United States
The Ohio State University /ID# 145444
🇺🇸Columbus, Ohio, United States
Holston Medical Group /ID# 145449
🇺🇸Bristol, Tennessee, United States
Drexel Univ College of Med /ID# 149789
🇺🇸Philadelphia, Pennsylvania, United States
Palmetto Clinical Research /ID# 150992
🇺🇸Summerville, South Carolina, United States
University Medical Group /ID# 148777
🇺🇸Greenville, South Carolina, United States
Venus Gynecology, LLC /ID# 145336
🇺🇸Myrtle Beach, South Carolina, United States
Vista Clinical Research /ID# 148767
🇺🇸Columbia, South Carolina, United States
Signature Gyn Services /ID# 145534
🇺🇸Fort Worth, Texas, United States
Puerto Rico Medical Research /ID# 152040
🇵🇷Ponce, Puerto Rico
The Jackson Clinic, PA /ID# 145303
🇺🇸Jackson, Tennessee, United States
WR-ClinSearch /ID# 145205
🇺🇸Chattanooga, Tennessee, United States
Gadolin Research, LLC /ID# 201383
🇺🇸Beaumont, Texas, United States
North Spokane Women's Health /ID# 145382
🇺🇸Spokane, Washington, United States
Advances in Health, Inc. /ID# 145425
🇺🇸Houston, Texas, United States
Precision Research Institute - Houston /ID# 154370
🇺🇸Houston, Texas, United States
The Woman's Hospital of Texas /ID# 145316
🇺🇸Houston, Texas, United States
Office of Edmond E. Pack, MD /ID# 148747
🇺🇸Las Vegas, Nevada, United States
Accent Clinical Trials /ID# 147109
🇺🇸Las Vegas, Nevada, United States
MD Strategies Research Centers /ID# 152429
🇺🇸San Diego, California, United States
Precision Research Institute - San Diego /ID# 152557
🇺🇸San Diego, California, United States
Carolina Women's Research and Wellness Center /ID# 145356
🇺🇸Durham, North Carolina, United States
CTI Clinical Research Center /ID# 145428
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati /ID# 145496
🇺🇸Cincinnati, Ohio, United States
Clinical Trials of Texas, Inc /ID# 147100
🇺🇸San Antonio, Texas, United States
VIP Trials /ID# 151745
🇺🇸San Antonio, Texas, United States
Centex Studies, Inc /ID# 148776
🇺🇸Houston, Texas, United States
FMC Science /ID# 150981
🇺🇸Lampasas, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 145363
🇺🇸San Antonio, Texas, United States
Alliance Research Centers /ID# 151240
🇺🇸Irvine, California, United States
Olympia Clinical Trials /ID# 202325
🇺🇸Los Angeles, California, United States
California Medical Research As /ID# 154746
🇺🇸Northridge, California, United States
Futura Research, Org /ID# 145406
🇺🇸Norwalk, California, United States
Helix Biomedics, LLC /ID# 147108
🇺🇸Boynton Beach, Florida, United States
KO Clinical Research, LLC /ID# 145410
🇺🇸Fort Lauderdale, Florida, United States
Clinical Physiology Associates /ID# 145237
🇺🇸Fort Myers, Florida, United States
Solutions Through Adv Rch /ID# 148768
🇺🇸Jacksonville, Florida, United States
Salom Tangir, LLC /ID# 148739
🇺🇸Miramar, Florida, United States
Meridien Research - St Petersburg /ID# 145345
🇺🇸Saint Petersburg, Florida, United States
Oncova Clinical Research, Inc. /ID# 148175
🇺🇸Saint Cloud, Florida, United States
Meridian Clinical Research, LLC /ID# 148176
🇺🇸Savannah, Georgia, United States
Atlanta Gynecology Research Institute /ID# 149322
🇺🇸Suwanee, Georgia, United States
Clinical Research Prime /ID# 161724
🇺🇸Idaho Falls, Idaho, United States
American Health Network of Ind /ID# 167996
🇺🇸Avon, Indiana, United States
Clinical Trials Management, LLC - Covington /ID# 145220
🇺🇸Covington, Louisiana, United States
Omni Fertility and Laser Insti /ID# 145532
🇺🇸Shreveport, Louisiana, United States
Continental Clinical Solutions /ID# 152041
🇺🇸Towson, Maryland, United States
Genesis Clinical Research - Fall River /ID# 148573
🇺🇸Fall River, Massachusetts, United States
Albuquerque Clinical Trials, Inc /ID# 154747
🇺🇸Albuquerque, New Mexico, United States
Bosque Women's Care /ID# 147084
🇺🇸Albuquerque, New Mexico, United States
Scott Research Inc. /ID# 161704
🇺🇸Laurelton, New York, United States
Hamburg Regional Gynecology Gr /ID# 161705
🇺🇸Orchard Park, New York, United States
Unified Women's Clinical Research-Greensboro /ID# 155543
🇺🇸Greensboro, North Carolina, United States
Eastern Carolina Women's Centr /ID# 145386
🇺🇸New Bern, North Carolina, United States
PMG Research of Wilmington /ID# 152555
🇺🇸Wilmington, North Carolina, United States
Aventiv Research, Inc. /ID# 145492
🇺🇸Columbus, Ohio, United States
Main Line Fertility Center /ID# 150099
🇺🇸Bryn Mawr, Pennsylvania, United States
Brown Clinic, PLLP /ID# 154372
🇺🇸Watertown, South Dakota, United States
UT Southwestern Medical Center /ID# 145201
🇺🇸Dallas, Texas, United States
Texas Health Presbyterian Hosp /ID# 150098
🇺🇸Dallas, Texas, United States
Center for Assisted Reprod. /ID# 154748
🇺🇸Bedford, Texas, United States
Next Innovative Clinical Research /ID# 203863
🇺🇸Houston, Texas, United States
Houston Ctr for Clin Research /ID# 148799
🇺🇸Sugar Land, Texas, United States
Corner Canyon Obstetrics and G /ID# 145519
🇺🇸Draper, Utah, United States
Southampton Women's Health /ID# 151691
🇺🇸Franklin, Virginia, United States
Tanner Clinic /ID# 148786
🇺🇸Layton, Utah, United States
Revere Health /ID# 145540
🇺🇸Pleasant Grove, Utah, United States
Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477
🇺🇸Newport News, Virginia, United States
Clinical Research Partners, LL /ID# 145392
🇺🇸North Chesterfield, Virginia, United States
Clinical Research Partners, LL /ID# 145416
🇺🇸North Chesterfield, Virginia, United States
Seattle Women's Health, Research, Gynecology /ID# 145341
🇺🇸Seattle, Washington, United States
Strand Clinic /ID# 152582
🇨🇦St. John's, Newfoundland and Labrador, Canada
Medicor Research Inc /ID# 151453
🇨🇦Sudbury, Ontario, Canada
The Ottawa Hospital /ID# 148927
🇨🇦Ottawa, Ontario, Canada
Clinical Research Puerto Rico /ID# 149018
🇵🇷San Juan, Puerto Rico
Victory Reproductive Care /ID# 149016
🇨🇦Windsor, Ontario, Canada
Rodriguez-Ginorio, San Juan /ID# 145545
🇵🇷San Juan, Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546
🇵🇷San Juan, Puerto Rico
PRN Professional Research Network of Kansas, LLC /ID# 151463
🇺🇸Wichita, Kansas, United States
Womens & Family Care, LLC dba /ID# 145211
🇺🇸Shawnee Mission, Kansas, United States
Cypress Medical Research Ctr /ID# 147159
🇺🇸Wichita, Kansas, United States
Trinity Health Center Town /ID# 147102
🇺🇸Minot, North Dakota, United States
Access Clinical Trials, Inc. /ID# 145224
🇺🇸Nashville, Tennessee, United States
Central Research Associates /ID# 163087
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC /ID# 145503
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC /ID# 151468
🇺🇸Birmingham, Alabama, United States
Oregon Health and Science University /ID# 155705
🇺🇸Portland, Oregon, United States
University of South Florida /ID# 145424
🇺🇸Tampa, Florida, United States
Stedman Clinical Trials /ID# 152554
🇺🇸Tampa, Florida, United States
Mobile, Ob-Gyn, P.C. /ID# 145364
🇺🇸Mobile, Alabama, United States
Downtown Womens Health Care /ID# 147955
🇺🇸Denver, Colorado, United States
The Women's Health Group - Thornton /ID# 203707
🇺🇸Thornton, Colorado, United States
Ocean Blue Medical Research Center, Inc /ID# 145514
🇺🇸Miami Springs, Florida, United States
Treasure Coast Research /ID# 148174
🇺🇸Stuart, Florida, United States
Physician Care Clin. Res., LLC /ID# 145511
🇺🇸Sarasota, Florida, United States
Genoma Research Group, Inc /ID# 152558
🇺🇸Miami, Florida, United States
Palmetto Professional Research /ID# 153838
🇺🇸Miami, Florida, United States
Comprehensive Clinical Trials /ID# 145148
🇺🇸West Palm Beach, Florida, United States
Agile Clinical Research Trials /ID# 145494
🇺🇸Atlanta, Georgia, United States
Apogee Women's Health Inc. /ID# 145149
🇺🇸College Park, Georgia, United States
Paramount Research Solutions /ID# 145226
🇺🇸Alpharetta, Georgia, United States
Women's Health Practice, LLC /ID# 145517
🇺🇸Champaign, Illinois, United States
Affinity Clinical Research /ID# 151469
🇺🇸Oak Brook, Illinois, United States
Center for Women's Research, Inc /ID# 145486
🇺🇸Palos Heights, Illinois, United States
Women's Health Advantage /ID# 145495
🇺🇸Fort Wayne, Indiana, United States
The Iowa Clinic /ID# 145409
🇺🇸West Des Moines, Iowa, United States
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459
🇺🇸Park Ridge, Illinois, United States
Wayne State University Physician Group - Southfield /ID# 145431
🇺🇸Southfield, Michigan, United States
Aventiv Research, Inc. /ID# 162896
🇺🇸Columbus, Ohio, United States
The Christ Hospital /ID# 149244
🇺🇸Cincinnati, Ohio, United States
University of Toledo /ID# 145403
🇺🇸Toledo, Ohio, United States
Wright State University & CTRA /ID# 145512
🇺🇸Fairborn, Ohio, United States
Penn State University and Milton S. Hershey Medical Center /ID# 145231
🇺🇸Hershey, Pennsylvania, United States
Frontier Clinical Research /ID# 162091
🇺🇸Smithfield, Pennsylvania, United States
Baylor Scott & White /ID# 170430
🇺🇸Fort Worth, Texas, United States
Willowbend Health and Wellness - Frisco /ID# 145245
🇺🇸Frisco, Texas, United States
Houston Methodist Hospital /ID# 170586
🇺🇸Houston, Texas, United States
Virginia Mason Medical Center /ID# 145387
🇺🇸Seattle, Washington, United States
Center of Reproductive Medicin /ID# 145467
🇺🇸Webster, Texas, United States
Madigan Army Medical Center /ID# 145186
🇺🇸Tacoma, Washington, United States
Advanced Women's Health Institute /ID# 145396
🇺🇸Greenwood Village, Colorado, United States
Suncoast Clinical Research /ID# 145484
🇺🇸New Port Richey, Florida, United States
Virtus Research Consultants, LLC /ID# 147101
🇺🇸Wellington, Florida, United States
Columbus Regional Research Ins /ID# 159752
🇺🇸Columbus, Georgia, United States
University of Pennsylvania /ID# 145470
🇺🇸Philadelphia, Pennsylvania, United States
Chattanooga Medical Research /ID# 145184
🇺🇸Chattanooga, Tennessee, United States
R. Garn Mabey Jr, MD Chartered /ID# 145361
🇺🇸Las Vegas, Nevada, United States
Bluegrass Clinical Research /ID# 151209
🇺🇸Louisville, Kentucky, United States
Northern California Research /ID# 159753
🇺🇸Sacramento, California, United States
University of Louisville /ID# 154751
🇺🇸Louisville, Kentucky, United States
ClinSite, LLC /ID# 145314
🇺🇸Ann Arbor, Michigan, United States
Ochsner Baptist OB/GYN Clinic /ID# 147144
🇺🇸New Orleans, Louisiana, United States
Women Under Study, LLC /ID# 151216
🇺🇸New Orleans, Louisiana, United States
Lotus Gynecology /ID# 148479
🇺🇸Austin, Texas, United States
AA (Austin Area) ObGyn PLLC /ID# 205696
🇺🇸Austin, Texas, United States
Sirius Clinical Research, LLC /ID# 154749
🇺🇸Austin, Texas, United States
Clinical Trials Virginia, Inc. /ID# 145430
🇺🇸Richmond, Virginia, United States
Alliance Womens Health /ID# 148770
🇺🇸Richmond, Virginia, United States
Clinical Inquest Center Ltd /ID# 147107
🇺🇸Beavercreek, Ohio, United States