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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522514-23-00 | EU Trial (CTIS) Number | ||
| J2A-MC-GZPS | Other Identifier | Eli Lilly and Company | |
| J2A-MC-GZS1 | Other Identifier | Eli Lilly and Company | |
| J2A-MC-GZS2 | Other Identifier | Eli Lilly and Company |
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The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2. Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity or overweight. SUI is leaking urine during movement or activity such as coughing or exercising. Participation in the study will last about 58 weeks from screening to safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron (GZS1) | Experimental | Participants will receive orforglipron orally |
|
| Placebo (GZS1) | Placebo Comparator | Participants will receive placebo orally |
|
| Orforglipron (GZS2) | Experimental | Participants will receive orforglipron orally |
|
| Placebo (GZS2) | Placebo Comparator | Participants will receive placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Incontinence Episode Frequency (IEF) | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 52 | |
| Change from Baseline in Urinary Incontinence-Specific Quality of Life | Baseline, Week 52 | |
| Change from Baseline in Number of Continence Pad (CAPD) Used Per Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama -The Kirklin Clinic | Recruiting | Birmingham | Alabama | 35233 | United States |
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| Label | URL |
|---|---|
| A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight (RESTRAIN-SUI) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered orally |
|
| Baseline, Week 52 |
| Change from Baseline in Patient Global Impression of Condition | Baseline, Week 52 |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 52 |
| Change from Baseline in Waist Circumference | Baseline, Week 52 |
| AMR Clinical | Recruiting | Mobile | Alabama | 36608 | United States |
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| Urologic Surgeons of Arizona | Recruiting | Mesa | Arizona | 85206 | United States |
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| Matrix Clinical Research | Recruiting | Los Angeles | California | 90057 | United States |
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| Alarcon Urology Center | Recruiting | Montebello | California | 90640 | United States |
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| Prestige Medical Group | Completed | Tustin | California | 92780 | United States |
| Colorado Clinical Research | Recruiting | Lakewood | Colorado | 80228 | United States |
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| AMR Clinical | Recruiting | Fort Myers | Florida | 33912 | United States |
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| Altus Research | Recruiting | Lake Worth | Florida | 33461 | United States |
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| New Age Medical Research Corporation | Recruiting | Miami | Florida | 33186 | United States |
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| Emerald Coast OBGYN Clinical Research | Recruiting | Panama City | Florida | 32405 | United States |
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| Teak Research Consults | Recruiting | Lawrenceville | Georgia | 30043 | United States |
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| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Recruiting | Troy | Michigan | 48098 | United States |
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| OB/GYN Associates of Erie | Recruiting | Erie | Pennsylvania | 16507 | United States |
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| Clinical Research of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19114 | United States |
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| Next Level Urgent Care | Recruiting | Houston | Texas | 77057 | United States |
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| Innovative Medical Research of Texas | Recruiting | Houston | Texas | 77065 | United States |
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| Health Research of Hampton Roads, Inc. | Recruiting | Newport News | Virginia | 23606 | United States |
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| Urology of Virginia | Recruiting | Virginia Beach | Virginia | 23462 | United States |
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| Northwest Clinical Research Center | Recruiting | Bellevue | Washington | 98007 | United States |
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| Seattle Clinical Research Center | Recruiting | Seattle | Washington | 98104 | United States |
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| OCT Research ULC | Recruiting | Kelowna | V1Y 1Z9 | Canada |
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| Kelowna Health and Memory Centre | Recruiting | Kelowna | V1Y 5A8 | Canada |
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| Alpha Recherche Clinique - Lévis | Recruiting | Lévis | G6V 0C9 | Canada |
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| The Fe/Male Health Centre | Recruiting | Oakville | L6H 3P1 | Canada |
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| Alpha Recherche Clinique | Recruiting | Québec | G2J 0C4 | Canada |
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| ALPHA Recherche Clinique | Recruiting | Québec | G3K 2P8 | Canada |
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| CaRe Clinic | Recruiting | Red Deer | T4P 1K4 | Canada |
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| Sunnybrook Research Institute | Recruiting | Toronto | M4N 3M5 | Canada |
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| Peking University First Hospital | Recruiting | Beijing | 100032 | China |
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| Peking University People's Hospital | Recruiting | Beijing | 100034 | China |
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| Xuanwu Hospital Capital Medical University | Recruiting | Beijing | 100053 | China |
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| Peking University Third Hospital | Recruiting | Beijing | 100091 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | 610072 | China |
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| Chengdu Women and Children Center Hospital | Recruiting | Chengdu | 610091 | China |
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| 2nd Affiliated Hospital Chongqing Medical University | Recruiting | Chongqing | 400010 | China |
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| Zhujiang Hospital | Recruiting | Guangzhou | 510280 | China |
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| The First Affiliated Hospital of Jinan University | Recruiting | Guangzhou | 510630 | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | 310014 | China |
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| Second Affiliated hospital of Anhui Medical University | Recruiting | Hefei | 230000 | China |
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| Gansu Provincial Hospital | Recruiting | Lanzhou | 730000 | China |
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| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Recruiting | Nanjing | 210000 | China |
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| Ningbo First Hospital | Recruiting | Ningbo | 315010 | China |
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| Obstetrics & Gynecology Hospital of Fudan University | Recruiting | Shanghai | 200011; 200090 | China |
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| Peking University Shenzhen Hospital | Recruiting | Shenzhen | 518036 | China |
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| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | 215004 | China |
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| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | 430030 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | 710061 | China |
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| The First Affiliated hospital of Xiamen University | Recruiting | Xiamen | 361003 | China |
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| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | 750004 | China |
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| Afimed - Urologicka ambulance | Recruiting | Benešov | 256 01 | Czechia |
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| Gynekologie Šottner | Recruiting | Brno | 603 00 | Czechia |
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| Centrum Panevniho Dna | Recruiting | Karlovy Vary | 360 17 | Czechia |
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| Kestr-gyn | Recruiting | Náchod | 547 01 | Czechia |
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| G-CENTRUM Olomouc | Recruiting | Olomouc | 772 00 | Czechia |
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| NEUMED gynekologická ambulance | Recruiting | Olomouc | 779 00 | Czechia |
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| GYNORD plus | Recruiting | Ostrava | 709 00 | Czechia |
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| Gyncare | Recruiting | Pilsen | 301 00 | Czechia |
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| Nestátní zdravotnické zařízení GONA | Recruiting | Prague | 110 00 | Czechia |
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| Devasya Superspeciality Kidney & Multispeciality Hospitals | Not yet recruiting | Ahmedabad | 380013 | India |
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| Apollo Hospitals Ahmedabad | Not yet recruiting | Ahmedabad | 382428 | India |
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| KLES Dr. Prabhakar Kore Hospital & M.R.C | Not yet recruiting | Belagavi | 590010 | India |
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| Belagavi Institute of Medical Sciences - Belagavi | Not yet recruiting | Belgavi | 590019 | India |
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| All India Institute of Medical Sciences | Not yet recruiting | Bhubaneswar | 751019 | India |
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| Postgraduate Institute of Medical Education & Research | Not yet recruiting | Chandigarh | 160012 | India |
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| Apollo Hospitals - Chennai | Not yet recruiting | Chennai | 600006 | India |
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| Malla Reddy Narayana Multispeciality Hospital | Not yet recruiting | Hyderabad | 500055 | India |
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| Ketki Nursing Home & Urology Hospital | Not yet recruiting | Nagpur | 440012 | India |
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| Sir Ganga Ram Hospital | Not yet recruiting | New Delhi | 110060 | India |
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| Lifepoint Multispeciality Hospital | Not yet recruiting | Pune | 411057 | India |
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| All India Institute of Medical Sciences | Not yet recruiting | Raipur | 492099 | India |
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| All India Institute of Medical Sciences - Rishikesh | Not yet recruiting | Rishikesh | 249203 | India |
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| Surat Institute of Digestive Sciences Hospitals | Not yet recruiting | Surat | 395002 | India |
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| Banaras Hindu University | Not yet recruiting | Varanasi | 221005 | India |
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| Hasegawa Hospital - Arakawa | Recruiting | Arakawa City | 116-0014 | Japan |
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| Takasu Nephrology and Urology Clinic | Recruiting | Chiba | 261-0004 | Japan |
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| Yotsuya Medical Cube | Recruiting | Chiyoda City | 102-0084 | Japan |
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| St. Luke's International Hospital | Recruiting | Chūōku | 104-8560 | Japan |
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| Mito Medical Center | Recruiting | Higashiibaraki | 311-3117 | Japan |
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| Nihon University Itabashi Hospital | Recruiting | Itabashiku | 173-8610 | Japan |
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| Kokura Memorial Hospital | Recruiting | Kitakyushu | 802-8555 | Japan |
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| Touyu Clinic | Recruiting | Matsudo | 270-0034 | Japan |
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| Tokyo Saiseikai Central Hospital | Recruiting | Minatoku | 108-0073 | Japan |
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| Koujunkai Daido Clinic | Recruiting | Nagoya | 457-8511 | Japan |
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| Women's Clinic LUNA NEXT STAGE | Recruiting | Naka-ku, Yokohama-Shi | 231-0861 | Japan |
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| Chiba Saiseikai Narashino hospital | Recruiting | Narashino | 275-8580 | Japan |
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| Nakazawa Nephrology and Urology Clinic | Recruiting | Nonoichi | 921-8824 | Japan |
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| Miyabi Urogyne Clinic | Recruiting | Okayama | 700-0822 | Japan |
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| Nakatsu Hospital | Recruiting | Osaka | 530-0012 | Japan |
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| Yukigaya Urology Clinic | Recruiting | Ōta-ku | 145-0065 | Japan |
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| Kashiwazaki Obstetrics and Gynecology Clinic | Recruiting | Saitama-shi | 330-0855 | Japan |
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| Izumi Chuo Hospital | Recruiting | Sendai | 981-3121 | Japan |
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| Toride Urology Clinic | Recruiting | Toride | 302-0021 | Japan |
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| Tsukuba Urocare Clinic | Recruiting | Tsukuba | 305-0821 | Japan |
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| Medical Center Metas | Recruiting | Chihuahua City | 31110 | Mexico |
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| Scientia Investigacion Clinica S.C. | Recruiting | Chihuahua City | 31207 | Mexico |
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| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. | Recruiting | Ciudad Madero | 89440 | Mexico |
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| Health Pharma Querétaro | Recruiting | Juriquilla | 76230 | Mexico |
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| RM Pharma Specialists - Unidad Especializada en Datos | Recruiting | Mexico City | 03100 | Mexico |
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| Centro de Oncología de Precisión - Mexico City | Not yet recruiting | Mexico City | 03330 | Mexico |
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| Quemex Medical and Research | Recruiting | Mexico City | 14308 | Mexico |
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| Medical Care and Research SA de CV | Recruiting | Mérida | 97070 | Mexico |
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| Clinstile, S.A. de C.V. | Not yet recruiting | México | 06700 | Mexico |
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| Jose Gerardo Garza Leal | Not yet recruiting | Monterrey | 64060 | Mexico |
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| Centro de investigación y control metabólico | Recruiting | Monterrey | 66465 | Mexico |
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| Centro de Investigacion Clinica Chapultepec | Not yet recruiting | Morelia | 58260 | Mexico |
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| Medimanage Research | Recruiting | Tlalpan | 14050 | Mexico |
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| IN VIVO | Recruiting | Bydgoszcz | 85-048 | Poland |
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| AIDPORT Sp. z o.o. | Recruiting | Skórzewo | 60-185 | Poland |
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| Centrum Medyczne Euromedis | Recruiting | Szczecin | 70-111 | Poland |
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| Medical Concierge Centrum Medyczne | Recruiting | Warsaw | 02-798 | Poland |
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| Centrum Medyczne Ginemedica | Recruiting | Wroclaw | 50-414 | Poland |
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| EMC Instytut Medyczny SA | Recruiting | Wroclaw | 54-239 | Poland |
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| Centrul Medical Unirea | Recruiting | Brasov | 500091 | Romania |
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| Spitalul Clinic Judetean de Urgenta (Brasov) | Recruiting | Brasov | 500152 | Romania |
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| Spitalul Clinic de Nefrologie Doctor Carol Davila | Recruiting | Bucharest | 010731 | Romania |
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| Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila | Not yet recruiting | Bucharest | 010825 | Romania |
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| Delta Health Care | Recruiting | Bucharest | 014142 | Romania |
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| Spitalul Clinic Colentina | Recruiting | Bucharest | 020125 | Romania |
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| Spitalul de Urgenta al Ministerului Administratiei si Internelor "Prof. Dr. Dimitrie Gerota" | Recruiting | Bucharest | 021373 | Romania |
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| Spitalul Clinic Județean de Urgență Ilfov | Recruiting | Bucharest | 022105 | Romania |
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| Fundeni Clinical Institute | Recruiting | Bucharest | 022328 | Romania |
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| Gnosis Evomed S.R.L. | Recruiting | Bucharest | 030913 | Romania |
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| Spitalul Clinic Profesor Doctor Theodor Burghele | Recruiting | Bucharest | 050659 | Romania |
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| Spitalul Clinic Județean de Urgență | Recruiting | Craiova | 200642 | Romania |
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| Spitalul Clinic Judetean De Urgenta Bihor | Recruiting | Oradea | 410169 | Romania |
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| Clinica Polisano | Recruiting | Sibiu | 550253 | Romania |
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| Polaris Medical SA | Recruiting | Suceagu | 407062 | Romania |
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| S.C. Materna Care S.R.L. | Recruiting | Timișoara | 300645 | Romania |
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| Spitalul Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara | Recruiting | Timișoara | 300723 | Romania |
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| Hallym University Sacred Heart Hospital | Recruiting | Anyang-si | 14068 | South Korea |
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| The Catholic University of Korea, Bucheon St. Mary's Hospital | Recruiting | Bucheon-si | 14647 | South Korea |
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| Pusan National University Hospital | Recruiting | Busan | 49241 | South Korea |
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| Chonnam National University Hospital | Recruiting | Gwangju | 61469 | South Korea |
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| Kyungpook National University Hospital | Recruiting | Junggu | 41944 | South Korea |
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| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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