Terminated/Withdrawn

Uterine fibroids

Bayer Identifier:

16953

ClinicalTrials.gov Identifier:

NCT03194646

EudraCT Number:

2016-004822-41

EU CT Number:

Not Available

Assess safety and efficacy of Vilaprisan in subjects with uterine fibroids

Trial purpose

The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

Key Participants Requirements

Sex

Female

Age

18 - N/A

Trial summary

Enrollment Goal

1272

Trial Dates

June 2017 - July 2024

Phase

Phase 3

Could I Receive a placebo

Products

Vilaprisan (BAY1002670)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Clinical Research Philadelphia \| Philadelphia, PA	Philadelphia, 19114, United States
Completed	Lyndhurst Clinical Research	Winston-Salem, 27103, United States
Completed	Unified Women's Clinical Research - Morehead City	Morehead City, 28557, United States
Completed	Carolina Women's Research & Wellness Center	Durham, 27713, United States
Completed	Visions Clinical Research - Tucson	Tucson, 85712, United States
Completed	Columbia University Medical Center	New York, 10032, United States
Withdrawn	Women's Health Associates of Southern Nevada (WHASN)	Las Vegas, 89106, United States
Completed	Helix Biomedics LLC \| Boynton Beach, FL	Boynton Beach, 33435, United States
Completed	Advances in Health, INC. \| Houston, TX	Houston, 77030, United States
Completed	Unified Women’s Clinical Research	Greensboro, 27408, United States
Completed	HWC Women's Research Center \| Englewood, OH	Englewood, 45322, United States
Completed	The Woman's Hospital of Texas	Houston, 77054, United States
Completed	Medical Center for Clinical Research	San Diego, 92108, United States
Completed	Centex Studies, Inc.	Lake Charles, 70601, United States
Completed	Sig Gyn Services (Dr. John A. Whitfield, MD) \| Fort Worth, TX	Fort Worth, 76104-4145, United States
Completed	M3 Wake Research \| Raleigh, NC	Raleigh, 27612, United States
Completed	Willowbend Health and Wellness Associates	Plano, 75093, United States
Completed	Miami Valley Hospital	Dayton, 45409-2793, United States
Completed	Tidewater Clinical Research \| Virginia Beach, VA	Norfolk, 23502, United States
Completed	OB-GYN Physicians, Inc.	Franklin, 23851, United States
Completed	Fellows Research Alliance, Inc \| Savannah, GA	Savannah, 31406, United States
Completed	Southern Clinical Research Associates \| Metairie, LA	Metairie, 70001, United States
Completed	PMG Research of Wilmington	Wilmington, 28401, United States
Completed	Carolinas Healthcare System	Charlotte, 28204, United States
Completed	Advanced Women's Health Institute \| Denver Office, Greenwood Village, CO	Parker, 80134, United States
Completed	Seven Oaks Women’s Center	San Antonio, 78229, United States
Completed	University of Arkansas for Medical Sciences	Little Rock, 72205, United States
Completed	Paramount Research Solutions \| College Park Location	College Park, 30349, United States
Completed	Physicians' Research Options, LLC \| Red Rocks OBGYN	Lakewood, 80228, United States
Completed	M3 Wake Research \| Clinical Research Center of Nevada	Las Vegas, 89123, United States
Completed	Johns Hopkins University School of Medicine	Columbia, 21044, United States
Completed	Solutions Through Advanced Research, Inc.	Jacksonville, 32256, United States
Completed	Atlanta Women's Research Institute, Inc. - Atlanta	Atlanta, 30342, United States
Withdrawn	John H Stroger Jr. Hospital of Cook County	Chicago, 60612, United States
Completed	Richmond ObGyn Associates PC	Staten Island, 10306, United States
Active, not recruiting	Augusta University Medical Center	Augusta, 30912, United States
Completed	Medisense Inc at Atlantic Station	Atlanta, 30364, United States
Completed	Suncoast Clinical Research Inc \| Pinellas	Palm Harbor, 34684, United States
Completed	Professional Research Network of Kansas, LLC	Wichita, 67203, United States
Completed	West Coast OB/GYN Associates	San Diego, 92123, United States
Completed	Peking Union Medical College Hospital CAMS	Beijing, 100730, China
Completed	Beijing Obstetrics and Gynecology Hospital,Capital Med.Uni.	Beijing, 100026, China
Completed	The First Affiliated Hospital of Dalian Medical University	Dalian, 116011, China
Completed	Beijing Hospital of Traditional Chinese Medicine	Beijing, 100010, China
Completed	The First Hospital of Jilin University	Changchun City, 130061, China
Completed	Tianjin Central Hospital of Gynecology obstetrics	Tianjin, 300199, China
Completed	Women's Clinic of Lincoln, P.C. \| Lincoln, NE	Lincoln, 68510, United States
Completed	Discovery Clinical Trials - Dallas	Dallas, 75231, United States
Completed	Coastal Clinical Research, Inc	Mobile, 36608, United States
Completed	M & O Clinical Research, LLC	Ft. Lauderdale, 33316, United States
Completed	Virginia Physicians For Women	North Chesterfield, 23235, United States
Completed	Capital Health \| Capital Health OBGYN Lawrenceville	Lawrenceville, 08648, United States
Completed	Clinical Trials of Viriginia	Richmond, 23225, United States
Completed	Journey Medical Research	Snellville, 30078, United States
Completed	Oregon Health and Science University	Portland, 97239, United States
Completed	Wayne State University Physicians Group	Detroit, 48201, United States
Completed	Agile Clinical Research Trials, LLC	Atlanta, 30328, United States
Completed	Bosque Women's Care \| Albuquerque, NM	Albuquerque, 87109, United States
Completed	Axcess Medical Research, LLC	Loxahatchee, 33470, United States
Completed	Stamford Hospital	Stamford, 06904, United States
Completed	Office of Dr. Delbert Alan Johns, MD	Fort Worth, 76104, United States
Completed	Suncoast Clinical Research Inc. \| Pasco	Trinity, 34655, United States
Active, not recruiting	Yale University School of Medicine	New Haven, 06511, United States
Completed	Lynn Health Science Institute \| Lynn Institute of the Ozarks	Little Rock, 72204, United States
Completed	Swor Women's Care	Sarasota, 34239, United States
Withdrawn	Wake Forest Baptist Health	Winston-Salem, 27103, United States
Completed	SUNY Downstate Medical Center	Brooklyn, 11203, United States
Completed	Center For Women's Research	Palos Heights, 60463, United States
Completed	Continental Clinical Solutions \| Towson, MD	Towson, 21204, United States
Completed	Diagnamics \| Encinitas, CA	Encinitas, 92024, United States
Completed	Vista Clinical Research	Columbia, 29201, United States
Completed	The 2nd Hospital of Hebei Medical University	Shijiazhuang, 50000, China
Completed	Women's Health Alliance	Raleigh, 27607, United States
Completed	MultiCare Health Systems Women's Health Care	Covington, 98042, United States
Completed	Omni Fertility and Laser Institute	Shreveport, 71118, United States
Withdrawn	Emerald Coast Clinical Research	Panama City, 32405, United States
Completed	IntimMedicine \| Washington, DC	Washington, 20036, United States
Completed	Penn State Milton S. Hershey Medical Center	Hershey, 17033, United States
Completed	Drexel University College of Medicine	Philadelphia, 19102, United States
Completed	Hospital of the University of Pennsylvania	Philadelphia, 19104, United States
Completed	Valaoras & Lewis OB/GYN	Winston-Salem, 27103, United States
Completed	Research Integrity, LLC	Owensboro, 42303, United States
Completed	Central Research Associates \| Birmingham, AL	Birmingham, 35205, United States
Withdrawn	Central Women's Health Care, PA	San Antonio, 78212, United States
Completed	ClinSearch, LLC	Hixson, 37421, United States
Completed	Women's Physician Group	Memphis, 38104, United States
Completed	VitaLink Research - Greenville	Greenville, 29615, United States
Completed	MacArthur OB/GYN Mangement, LLC	Irving, 75062, United States
Completed	Grossmont Center for Clinical Research	La Mesa, 91942, United States
Completed	Venus Gynecology, LLC \| Myrtle Beach, SC	Myrtle Beach, 29572, United States
Completed	Women's Medical Research Group, LLC	Clearwater, 33759, United States
Completed	Baltimore Suburban Health, LLC	Pikesville, 21208, United States
Completed	Medical University of South Carolina \| MUSC Center for Womens Health - Department of Obstetrics and Gynecology	Charleston, 29425, United States
Completed	Synexus Research, LLC	Richmond, 23226, United States
Completed	Invocare Clinical Research Center, LLC	West Columbia, 29169, United States
Completed	ONCOVA Clinical Research, Inc.	Saint Cloud, 34769, United States
Completed	Family Medicine Clinic	Georgetown, 78626, United States
Completed	Women's Health Care Research \| San Diego, CA	San Diego, 92111, United States
Withdrawn	Dedicated Women's Health Specialists, Inc.	Puyallup, 98372, United States
Withdrawn	Rapid Medical Research Inc.	Cleveland, 44122, United States
Completed	Manhattan Medical Research	New York, 10016, United States
Completed	Eastern Carolina Women's Center \| New Bern, NC	New Bern, 28562, United States
Completed	Jersey Shore University Medical Center	Neptune, 07753, United States
Withdrawn	Hospital Sanitas La Zarzuela	Aravaca, 28023, Spain
Withdrawn	H Virgen del Rocio \|Cardiology\|AF\|Stroke prevention	Sevilla, 41013, Spain
Withdrawn	Hospital de la Santa Creu i Sant Pau \| Gynecology Department	Barcelona, 08025, Spain
Withdrawn	Hospital Clínic i Provincial de Barcelona	Barcelona, 08036, Spain
Completed	Scien. Res. Institute of Obsterics, Gyn. & Reproduction	St. Petersburg, 199034, Russia
Completed	"Granti-Med"	St. Petersburg, 198329, Russia
Completed	St. Petersburg Medical University n.a. I.P. Pavlov	St. Petersburg, 197022, Russia
Withdrawn	Smolensk State Medical University	Smolensk, 214019, Russian Federation
Completed	City Clinical Hospital #13 Moscow	Moscow, 115280, Russia
Completed	Close Joint Stock Company "Medical Company IDK"	Samara, 443072, Russia
Completed	Regional Clinical Hospital #2	Krasnodar, 350012, Russia
Completed	Endocrinology Research Center	Moscow, 117036, Russia
Completed	Krasnoyarsk regional perinatal center	Krasnoyarsk, 660074, Russia
Completed	Scientific Center of family health & human reprod. problems	Irkutsk, 664003, Russia
Completed	Peking University First Hospital	Beijing, 100034, China
Completed	SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV.	Guangzhou, 510120, China
Completed	Wuhan Tongji Reproductive Medicine Hospital	Wuhan, 430013, China
Completed	First Teaching Hosptial of Tianjin University of TCM	Tianjin, 300193, China
Completed	Tianjin Medical University General Hospital	Tianjin, 300052, China
Withdrawn	University of Connecticut Health Center	Farmington, 06032, United States
Completed	Centrum gynekologicke rehabilitace	Písek, 397 01, Czech Republic
Completed	Fakultni nemocnice Brno	Brno, 625 00, Czech Republic
Completed	G-Centrum Olomouc s.r.o. Dr. Skrivanek	Ceske Budejovice, 370 01, Czech Republic
Completed	Fakultni Nemocnice Hradec Kralove	Hradec Kralove, 500 05, Czech Republic
Withdrawn	Femina Sana s.r.o	Praha, 13000, Czechia
Completed	Fakultni Nemocnice Olomouc	Olomouc, 77900, Czech Republic
Completed	Dr. Smrhova-Kovacs	Tabor, 39003, Czech Republic
Completed	Clinical Inquest Center, Ltd.	Beavercreek, 45432, United States
Completed	Praetorian Pharmaceutical Research, LLC	Marrero, 70072, United States
Completed	Women's Health Alliance of Mobile	Mobile, 36604, United States
Completed	Kagawa Prefectural Central Hospital	Takamatsu, 760-8557, Japan
Completed	Ginza Yoshida Clinic	Chuo-ku, 104-0061, Japan
Withdrawn	GYNET Lekarske centrum s.r.o.	Ostrava, 700 30, Czechia
Completed	Mehilainen \| Mehilainen Kuopio	Kuopio, 70100, Finland
Completed	Lääkärikeskus Gyneko, Gynaecological Medical Center \| Oulu, Finland	Oulu, 90100, Finland
Withdrawn	Kymenlaakson keskussairaala	Kotka, 48210, Finland
Withdrawn	Keski-Suomen sairaala Nova	Jyväskylä, 40620, Finland
Completed	Dr. Victoria Garcia & Associates, LLC Doral Medical Research	Doral, 33166, United States
Completed	Hashimoto Clinic	Sapporo, 004-0052, Japan
Completed	Yoshio Clinic	Sapporo, 064-0808, Japan
Completed	Juno Vesta Clinic Hatta	Matsudo, 270-2267, Japan
Completed	Medical corporation keizukai Chayamachi Ladies Clinic	Osaka, 530-0013, Japan
Completed	Kurashiki Medical Clinic	Kurashiki, 710-0824, Japan
Completed	Aso Iizuka Hospital	Iizuka, 820-8505, Japan
Completed	Medical Corporation Koshinkai Nomura Clinic Namba	Osaka, 542-0076, Japan
Completed	Medical Topia Soka Hospital	Soka, 340-0028, Japan
Completed	SAPPORO MEDICAL CENTER, NTT East Corporation	Sapporo, 060-0061, Japan
Completed	Ishikawa Prefectural Central Hospital	Kanazawa, 920-8530, Japan
Completed	Second Kawasaki Saiwai Clinic	Kawasaki, 212-0021, Japan
Completed	Sapporo Shiroishi Obstetrics and Gynecology Hospital	Sapporo, 003-0005, Japan
Completed	Sapporo West Ladies Clinic	Sapporo, 063-0061, Japan
Completed	Chayamachi ladies Clinic Hommachi	Osaka, 541-0048, Japan
Completed	Ena Odori Clinic	Sapporo, 060-0001, Japan
Completed	Sei Womens Clinic	Bunkyo, 112-0014, Japan
Completed	Suita Municipal Hospital	Suita, 564-0082, Japan
Completed	Medical Corp. Seikoukai New Medical Research System Clinic	Hachioji, 192-0046, Japan
Completed	Ikebukuro Metropolitan Clinic	Toshima-ku, 171-0021, Japan
Completed	Shirokane Ladies' Clinic	Minato, 108-0071, Japan
Completed	Yokokura Clinic	Minato-ku, 108-0014, Japan
Completed	Women's wellness Tsushima Ruriko josei life clinic Ginza	Chuo-ku, 104-0061, Japan
Completed	Fuyo Association Seirei Numazu Hospital	Numazu, 410-8555, Japan
Completed	St.Luke's International Hospital	Chuoku, 104-8560, Japan
Completed	Kato Internal medicine and Gynecology Clinic	Fukui, 910-0845, Japan
Completed	Sato Hospital	Takasaki, 370-0836, Japan
Completed	Kugayama Hospital	Setagaya-ku, 157-0061, Japan
Withdrawn	Hamanomachi Hospital	Fukuoka, 810-8539, Japan
Completed	Sano Wemen's Clinic	Fukuoka, 810-0062, Japan
Withdrawn	Tottori University Hospital	Yonago, 683-8504, Japan
Completed	IZUMA CLINIC	Osaka, 543-0023, Japan
Completed	Kano's Clinic for Women	Nagoya, 460-0011, Japan
Completed	Toranomon Womens Clinic	Minato, 105-0001, Japan
Completed	Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic	Minato, 107-0051, Japan
Completed	Jusendo Geneal Hospital Yuasa Foundation	Koriyama, 963-8585, Japan
Completed	Akazawa Clinic	Fuchu, 183-0056, Japan
Completed	International Peace Maternity&Child Health Hospital of CWI	Shanghai, 200030, China
Completed	West China Second University Hospital	Chengdu, 610041, China
Completed	Beijing Tiantan Hospital, Captial Medical University	Beijing, 100050, China
Completed	Shandong Provincial Hospital	Jinan, 250021, China
Completed	The Second Affiliated Hospital of Shanxi Medical University	Taiyuan, 30001, China
Withdrawn	Daping Hospital, 3rd Affil Hosp. 3rd Military Med Univ PLA	Chongqing, 400042, China
Completed	The First Affiliated Hospital of Xinjiang Medical University	Urumchi, MISSING, China
Withdrawn	Guangzhou Women and Children's Medical Center	Guangzhou, 510623, China
Withdrawn	Hospital Regional de Málaga	Málaga, 29011, Spain
Withdrawn	Hospital General Universitario de Valencia	Valencia, 46014, Spain
Completed	Nesttun Spesialistpraksis AS	Nesttun, 5221, Norway
Completed	Kirkeparken Spesialistpraksis	Fredrikstad, 1605, Norway
Withdrawn	Stavanger UHospital Cardiology	Stavanger, 4011, Norway
Completed	Medicus AS	Trondheim, 7014, Norway
Completed	Women's Hospital School of Medicine Zhejiang University	Hangzhou, 310006, China
Completed	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning, 530021, China
Completed	Prywatna Klinika Ginekologiczno-Poloznicza	Bialystok, 15-244, Poland
Completed	Centrum Medyczne Chodzki	Lublin, 20-093, Poland
Completed	Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.	Lodz, 90-602, Poland
Completed	Specjalistyczny Gabinet Ginekologiczno-Polozniczy	Lublin, 20-400, Poland
Completed	CLINICAL MEDICAL RESEARCH Sp. z o. o.	Katowice, 40-156, Poland
Completed	Vita Longa Sp. z o.o.	Katowice, 40-748, Poland
Completed	Gyncentrum Sp. z o.o.	Katowice, 40-851, Poland
Completed	Zhongda Hospital Southeast University	Nanjing, 210009, China
Completed	Queen Mary Hospital	Hong Kong, MISSING, Hong Kong
Withdrawn	Hospital Angeles Centro Medico del Potosí	San Luis Potosí, 78200, Mexico
Withdrawn	Hospital Zambrano Hellion	Monterrey, 66278, Mexico
Completed	Sanatorio Alcocer Pozo S. A. de C. V.	Querétaro, 76000, Mexico
Completed	Centro Integral Médico de San Juan del Río S. C.	San Juan del Río, 76800, Mexico
Withdrawn	Hospital Angeles "Acoxpa"	Ciudad de México, 14308, Mexico
Completed	Dr L Reynders Practice	Lyttelton Manor, 141, South Africa
Completed	Clintrials Centre for Clinical Research	Panorama, 7500, South Africa
Completed	Nanjing Maternity and Child Health Care Hospital	Nanjing, 210004, China
Completed	NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School	Nanjing, 210008, China
Completed	Shizuoka Saiseikai General Hospital	Shizuoka, 422-8527, Japan
Completed	Unoki Clinic	Kagoshima, 892-0826, Japan
Completed	Tokyo Women's Medical University Hospital	Shinjuku-ku, 162-8666, Japan
Completed	Changhai Hospital of Second Military Medical University	Shanghai, 200433, China
Completed	The First Affiliated Hospital of Guangzhou University of TCM	Guangzhou, 510405, China
Completed	The Second Affliated Hospital of Wenzhou Medicial University	Wenzhou, 325000, China
Withdrawn	The Second Xiangya Hospital of Central South University	Changsha, 410011, China
Completed	The Second Affiliated Hospital of Nanchang University	Nanchang, 330200, China
Completed	900th Hospital of Joint Logistics Support Force	Fuzhou, 350025, China
Completed	Hainan General Hospital	Haikou, 570311, China
Withdrawn	The First Hospital of Changsha	Changsha, 410005, China
Completed	The Third Affiliated Hospital, Sun Yat-Sen University	Guangzhou, 510630, China
Completed	Peking University Shenzhen Hospital	Shenzhen, 518036, China
Completed	Sapporo Maternity Women's Minami1jo Clinic	Sapporo, 060-0061, Japan
Completed	Primo Women's Clinic	Ebetsu, 067-0031, Japan
Completed	Sapporo Maternity Women's Hospital	Sapporo, 001-0013, Japan
Completed	Kyoritsu Narashinodai Hospital	Funabashi, 274-0063, Japan
Completed	Shizuoka City Shimizu Hospital	Shizuoka, 424-8636, Japan
Withdrawn	Kamoi Women General Clinic	Yokohama, 224-0053, Japan
Completed	Asahi-Clinic	Takamatsu, 760-0076, Japan
Withdrawn	Meitetsu Hospital	Nagoya, 451-8511, Japan
Withdrawn	Unidad Integral de Endocrinologia UNIENDO	Bogotá, Colombia
Withdrawn	Fundacion Centro de Investigaciones Clinicas CIC	Medellín, TBC, Colombia
Withdrawn	Hospital Pablo Tobón Uribe	Medellín, 050034, Colombia
Withdrawn	Clínica Imbanaco S.A.S	Cali, 760042, Colombia
Withdrawn	Caja de Compensación Familiar CAFAM	Bogota, 111061, Colombia
Withdrawn	Toyama Prefectural Central Hospital	Toyama, 930-8550, Japan
Completed	Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi	Istanbul, 34098, Turkey
Active, not recruiting	Istanbul Universitesi Istanbul Tip Fakultesi	Istanbul, 34093, Turkey
Completed	Uludag Universitesi Tip Fakultesi	Bursa, 16059, Turkey
Active, not recruiting	Ankara Universitesi Tip Fakultesi Hastanesi	Ankara, 6100, Turkey
Active, not recruiting	Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast	Ankara, TBC, Turkey
Active, not recruiting	Cukurova Universitesi Tip Fakultesi Hastanesi	Adana, TBC, Turkey
Completed	Femway Inc	Umhlanga, 4321, South Africa
Completed	Durban International Clinical Research Site	Wentworth, 4052, South Africa
Completed	Drs AEVITAS Clinic (Pty) Ltd	Cape Town, 7405, South Africa
Completed	University of Pretoria, Clinical Research Unit	Pretoria, 2, South Africa
Withdrawn	TREAD Research cc	Cape Town, 7500, South Africa
Completed	University of Cape Town Clinical Research Centre	Cape Town, 7925, South Africa
Completed	Siriraj Hospital, Mahidol	Bangkok, 10700, Thailand
Completed	King Chulalongkorn Memorial Hospital	Bangkok, 10330, Thailand
Completed	Hospital Universitario "José Eleuterio González"	Monterrey, TBC, Mexico
Withdrawn	Hospital General de Zona 1A "Venados"	Ciudad de México, 3300, Mexico
Withdrawn	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin, 71-434, Poland
Active, not recruiting	Henry Ford Health System	Detroit, 48202, United States
Completed	MUDr. Pavlina Nejedla s.r.o.	Vodnany, 389 01, Czech Republic
Withdrawn	UMAE Hospital de Gineco Obstetricia No 4 Luis Castelazo IMSS	Ciudad de Mexico, 1090, Mexico
Completed	Jiangxi Maternal and Child Health Hospital	Nanchang, 330006, China
Completed	MUDr. Radek Fiker s.r.o.	Jihlava, 586 01, Czech Republic
Withdrawn	VL-Medi Oy	Helsinki, 00510, Finland

Primary Outcome

Percentage change in bone mineral density (BMD) of lumbar spine
The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.
Time Frame:
From baseline to about 1 year after start of treatment

Secondary Outcome

Number of bleeding days
Number of bleeding days were defined from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 days
Time Frame:
Treatment phase: approximately 1 year
Number of participants with endometrial histology findings by endometrial biopsy main results (majority read, main diagnosis)
Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy
Time Frame:
Up to 3 years (from study treatment start to end of study)
Change from baseline in endometrial thickness
Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline (worst measurement during baseline period) in endometrial thickness was provided in below table.
Time Frame:
Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Percentage change from baseline in BMD measured at lumbar spine (other time points not mentioned as primary safety variable) and hip/femoral neck
Percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable.
Time Frame:
Treatment phase: approximately 1 year, follow-up phase: up to 2 years

Trial design

An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of vilaprisan in subjects with uterine fibroids versus standard of care

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

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