ASTRID: Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence

• Sponsor: GTx (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03241342
• Collaborator: (none)
• Enrollment: 491
• Locations: 62
• Arms: 3
• Actual Duration (Months): 13
• Patients Per Site: 7.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in postmenopausal women. Urinary incontinence and pelvic floor disorders are major health problems for women, especially as they age. Pelvic floor muscle relaxation has been found to correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and lower urinary tract are crucial for supporting the pelvic organs and micturition; however, damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass and strength, lack of oral bioavailability and known potential risks have limited their use. Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower urinary tract disorders, as both testosterone and its more potent metabolite, dihydrotestosterone, have anabolic effects on muscle.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Drug: GTx 024; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 491 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double-blind, placebo-controlled, parallel design, randomized, multicenter, Phase 2 study consisting of the following periods: screening period, treatment period, and follow-up period.Double-blind, placebo-controlled, parallel design, randomized, multicenter, Phase 2 study consisting of the following periods: screening period, treatment period, and follow-up period.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Double-Blind, Placebo-Controlled, Parallel Design, Phase 2 Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
• Actual Study Start Date: Aug 21, 2017
• Actual Primary Completion Date: Sep 21, 2018
• Actual Study Completion Date: Sep 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 mg GTx-024 Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.	Drug: GTx 024; Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.; Other Names: Enobosarm
Active Comparator: 3 mg GTx-024 Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.	Drug: GTx 024; Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.; Other Names: Enobosarm
Placebo Comparator: matching placebo Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.	Drug: Placebo; Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12 [12 Weeks]

   Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• SUI symptoms of at least 6 months duration

• Predominant SUI as determined at the Screening Visit using the Medical, Epidemiological, and Social Aspects of Aging (MESA) urinary questionnaire.

• 24-Hour pad weight > 3 g during the screening period

• A minimum of 1 and no more than 15 SUI episodes on any single day AND no fewer than 9 total SUI episodes over 3 days during the screening period

• Positive bladder stress test conducted during the Screening Visit

Key Exclusion Criteria:

• History of pelvic radiation treatment

• History of urethral diverticula

• History of urethral sling or anterior prolapse repair

• Treatment with urethral bulking agents and/or other SUI procedure or surgery within the 6 months prior to the Screening Visit

• Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities

• Urinary incontinence of neurogenic etiology

• Morbidly obese (defined as 100 pounds over ideal body weight, or body mass index 40 or greater)

• Chronic hepatitis

• Hepatic cirrhosis

• Evidence of active infection with hepatitis B or hepatitis C

• History of human immunodeficiency virus (HIV) infection

• Subjects with a history of breast or endometrial cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology Center of Alabama	Homewood	Alabama	United States	35209
2	Coastal Clinical Research Inc	Mobile	Alabama	United States	36608
3	Alaska Clinical Research Center	Anchorage	Alaska	United States	99503
4	Mayo Clinic Arizona	Phoenix	Arizona	United States	85054
5	Urological Associates of Southern Arizona	Tucson	Arizona	United States	85741
6	Women's Healthcare Research Corporation	San Diego	California	United States	92111
7	American Institute of Research	Whittier	California	United States	90603
8	Genitourinary Surgical Consultants	Denver	Colorado	United States	80220
9	Urology Associates Research	Englewood	Colorado	United States	80113
10	Women's Health Specialty Care	Farmington	Connecticut	United States	06032
11	Coastal Connecticut Research, LLC	New London	Connecticut	United States	06320
12	Bladder Control Center of Connecticut	Norwalk	Connecticut	United States	06859
13	James A Simon MD PC	Washington	District of Columbia	United States	20036
14	South Florida Medical Research	Aventura	Florida	United States	33180
15	Tampa Bay Medical Research Inc	Clearwater	Florida	United States	33761
16	Midland Florida Clinical Research Center LLC	DeLand	Florida	United States	32720
17	Precision Clinical Research	Lauderdale Lakes	Florida	United States	33319
18	Lone Star Research Center	Miami	Florida	United States	33145
19	Medical Research of Florida	Miami	Florida	United States	33186
20	Clinical Research Center of Florida	Pompano Beach	Florida	United States	33060
21	Mount Vernon Clinical Research LLC	Sandy Springs	Georgia	United States	30328
22	Clinical Research Prime	Idaho Falls	Idaho	United States	83221
23	Idaho Urologic Institue	Meridian	Idaho	United States	83642
24	Women's Health Institution of Illinois	Oak Lawn	Illinois	United States	60453
25	First Urology PSC	Jeffersonville	Indiana	United States	47130
26	Iowa Clinic	West Des Moines	Iowa	United States	50266
27	DelRicht Clinical Research, LLC	New Orleans	Louisiana	United States	70115
28	Regional Urology	Shreveport	Louisiana	United States	71106
29	Chesapeake Urology Associates PA	Hanover	Maryland	United States	21076
30	Boston Clinical Trials	Boston	Massachusetts	United States	02131
31	Bay State clinical Trials	Watertown	Massachusetts	United States	02472
32	Beyer Research	Kalamazoo	Michigan	United States	49009
33	William Beaumont Hospital Urology Research	Royal Oak	Michigan	United States	48073
34	Women's Clinic of Lincoln	Lincoln	Nebraska	United States	68510
35	Sheldon J Freedman MD Ltd	Las Vegas	Nevada	United States	89144
36	Premier Urology Group, LL	Edison	New Jersey	United States	08837
37	Lawrence Obs Gyn clinical Research	Lawrenceville	New Jersey	United States	08648
38	Delaware Valley Urology	Mount Laurel	New Jersey	United States	08054
39	Accumed Research Associates	Garden City	New York	United States	11530
40	Manhattan Medical Research Practice PLLC	New York	New York	United States	10016
41	Premier Medical Group	Poughkeepsie	New York	United States	12601
42	Circuit Clinical	West Seneca	New York	United States	14224
43	American Health Research Inc	Charlotte	North Carolina	United States	28207
44	Alliance Urology Specialist PA	Greensboro	North Carolina	United States	27403
45	Eastern Carolina Women's	New Bern	North Carolina	United States	28562
46	The Urology Group	Cincinnati	Ohio	United States	45212
47	Cleveland Clinic	Cleveland	Ohio	United States	44195
48	Aventiv Research	Columbus	Ohio	United States	43213
49	Institute for Female Pelvic Medicine	Allentown	Pennsylvania	United States	18103
50	Urologic Consultants of Southeastern PA LLP	Bala-Cynwyd	Pennsylvania	United States	19004
51	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104
52	Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
53	Carolina Urologic Research	Myrtle Beach	South Carolina	United States	29572
54	The Jackson Clinic	Jackson	Tennessee	United States	38305
55	Elligo - Austin Area OBGYN	Austin	Texas	United States	78758
56	Urology Clinics of North Texas	Dallas	Texas	United States	75231
57	Clinical Trials of Texas Incorporated	San Antonio	Texas	United States	78229
58	Urology San Antonio Research PA	San Antonio	Texas	United States	78229
59	Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice	Layton	Utah	United States	84041
60	Urology of Virginia	Virginia Beach	Virginia	United States	23462
61	Urology Northwest PS	Mountlake Terrace	Washington	United States	98043
62	Seattle Womens: Health, Research, Gynocology	Seattle	Washington	United States	98105

Sponsors and Collaborators

• GTx

Investigators

• Principal Investigator: Kenneth M Peters, MD, Oakland University, William Beaumont School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 10, 1018

More Information

Publications

None provided.

• Responsible Party: GTx
• ClinicalTrials.gov Identifier: NCT03241342
• Other Study ID Numbers: G201002
• First Posted: Aug 7, 2017
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

Participant Flow

Arm/Group Title	1 mg GTx-024	3 mg GTx-024	Matching Placebo
Arm/Group Description	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
Period Title: Overall Study
STARTED	163	163	165
COMPLETED	141	132	138
NOT COMPLETED	22	31	27

Baseline Characteristics

Arm/Group Title	1 mg GTx-024	3 mg GTx-024	Matching Placebo	Total
Arm/Group Description	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.	Total of all reporting groups
Overall Participants	163	163	165	491
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60	59	58	59
Sex: Female, Male (Count of Participants)
Female	163 100%	163 100%	165 100%	491 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	13 8%	10 6.1%	15 9.1%	38 7.7%
Not Hispanic or Latino	149 91.4%	152 93.3%	150 90.9%	451 91.9%
Unknown or Not Reported	1 0.6%	1 0.6%	0 0%	2 0.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 1.8%	2 1.2%	1 0.6%	6 1.2%
Asian	1 0.6%	1 0.6%	1 0.6%	3 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 0.6%	1 0.2%
Black or African American	25 15.3%	20 12.3%	12 7.3%	57 11.6%
White	131 80.4%	139 85.3%	150 90.9%	420 85.5%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	3 1.8%	1 0.6%	0 0%	4 0.8%
Baseline number of stress incontinence episodes per day (episodes per day) [Mean (Full Range) ]
Mean (Full Range) [episodes per day]	4.588	4.329	4.459	4.4

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12
Description	Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

full analysis set

Arm/Group Title	1 mg GTx-024	3 mg GTx-024	Matching Placebo
Arm/Group Description	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
Measure Participants	163	163	165
Count of Participants [Participants]	94 57.7%	96 58.9%	87 52.7%

Adverse Events

Time Frame	7 months
Arm/Group Title	1 mg GTx-024		3 mg GTx-024		Matching Placebo
Arm/Group Description	Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.		Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.		Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. Placebo: Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
All Cause Mortality
	1 mg GTx-024		3 mg GTx-024		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/163 (0%)		0/163 (0%)		0/165 (0%)
Serious Adverse Events
	1 mg GTx-024		3 mg GTx-024		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/163 (1.8%)		2/163 (1.2%)		4/165 (2.4%)
Cardiac disorders
acute myocardial infarction	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
Endocrine disorders
goiter	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
Infections and infestations
abscessed limb	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
osteomyelitis	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
Injury, poisoning and procedural complications
hip fracture	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
Musculoskeletal and connective tissue disorders
spinal disorder	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
Nervous system disorders
cerebral vascular accident	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
dysaesthesia	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
Respiratory, thoracic and mediastinal disorders
pulmonary congestion	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
respiratory failure	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
Other (Not Including Serious) Adverse Events
	1 mg GTx-024		3 mg GTx-024		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	105/163 (64.4%)		104/163 (63.8%)		96/165 (58.2%)
Blood and lymphatic system disorders
anemia	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
lymphadenopathy	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
polycythaemia	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
thrombocytosis	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
Cardiac disorders
acute myocardial infarction	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
cardiomegaly	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
palpitations	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
Ear and labyrinth disorders
ear discomfort	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
motion sickness	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
vertigo	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
Endocrine disorders
goiter	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
hypothyroidism	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
Eye disorders
blepharitis	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
chalazion	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
dry eye	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
eye discharge	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
eye pain	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
eye swelling	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
vision blurred	2/163 (1.2%)		0/163 (0%)		1/165 (0.6%)
visual impairment	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
Gastrointestinal disorders
abdominal discomfort	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
abdominal distension	2/163 (1.2%)		0/163 (0%)		2/165 (1.2%)
abdominal hernia	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
abdominal pain	2/163 (1.2%)		1/163 (0.6%)		2/165 (1.2%)
abdominal pain lower	0/163 (0%)		1/163 (0.6%)		2/165 (1.2%)
abdominal pain upper	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
change of bowel habit	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
colitis	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
constipation	4/163 (2.5%)		3/163 (1.8%)		3/165 (1.8%)
diarrhea	2/163 (1.2%)		3/163 (1.8%)		5/165 (3%)
diverticulum	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
dry mouth	1/163 (0.6%)		5/163 (3.1%)		4/165 (2.4%)
dyspepsia	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
eructation	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
flatulence	1/163 (0.6%)		0/163 (0%)		2/165 (1.2%)
food poisoning	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
gastritis	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
hemorrhoids	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
nausea	4/163 (2.5%)		4/163 (2.5%)		7/165 (4.2%)
oesophageal stenosis	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
vomiting	2/163 (1.2%)		0/163 (0%)		1/165 (0.6%)
General disorders
chest pain	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
cyst	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
energy increased	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
fatigue	2/163 (1.2%)		3/163 (1.8%)		3/165 (1.8%)
feeling abnormal	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
feeling hot	0/163 (0%)		1/163 (0.6%)		1/165 (0.6%)
hypothermia	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
influenza like illness	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
malaise	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
non cardiac chest pain	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
oedema peripheral	7/163 (4.3%)		3/163 (1.8%)		1/165 (0.6%)
peripheral swelling	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
polyp	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
pyrexia	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
thirst	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
Immune system disorders
hypersensitivity	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
Infections and infestations
abscess limb	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
acute sinusitis	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
bronchitis	3/163 (1.8%)		3/163 (1.8%)		3/165 (1.8%)
candida infection	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
cellulitis	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
clostridium difficile infection	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
diverticulitis	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
ear infection	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
escherichia	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
eye infection	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
fungal infection	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
gastroenteritis	0/163 (0%)		2/163 (1.2%)		1/165 (0.6%)
gastroenteritis viral	0/163 (0%)		0/163 (0%)		2/165 (1.2%)
genital herpes	0/163 (0%)		3/163 (1.8%)		0/165 (0%)
herpes zoster	3/163 (1.8%)		0/163 (0%)		0/165 (0%)
influenza	3/163 (1.8%)		3/163 (1.8%)		3/165 (1.8%)
localized infection	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
mycoplasma infection	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
nasopharyngitis	4/163 (2.5%)		7/163 (4.3%)		6/165 (3.6%)
osteomyelitis	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
otitis media acute	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
pharyngitis	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
pneumonia	1/163 (0.6%)		1/163 (0.6%)		3/165 (1.8%)
post procedural infection	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
respiratory tract infection viral	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
rhinitis	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
sinusitis	0/163 (0%)		2/163 (1.2%)		0/165 (0%)
streptococcal infection	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
tooth infection	1/163 (0.6%)		1/163 (0.6%)		1/165 (0.6%)
upper respiratory tract infection	7/163 (4.3%)		7/163 (4.3%)		10/165 (6.1%)
urinary tract infection	17/163 (10.4%)		29/163 (17.8%)		18/165 (10.9%)
urinary tract infection fungal	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
vaginal infection	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
viral infection	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
vulvovaginal mycotic infection	2/163 (1.2%)		0/163 (0%)		1/165 (0.6%)
Injury, poisoning and procedural complications
arthropod bite	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
contusion	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
fall	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
foot fracture	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
hip fracture	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
joint injury	0/163 (0%)		1/163 (0.6%)		1/165 (0.6%)
laceration	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
ligament rupture	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
ligament sprain	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
post procedural haematoma	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
procedural pain	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
radius fracture	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
rib fracture	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
soft tissue injury	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
sternal fracture	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
tendon rupture	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
tibia fracture	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
tooth fracture	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
Investigations
alanine aminotransferase increasae	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
aspartate aminotransferase increase	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
blood alkaline phosphatase increase	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
blood creatinine phophokinase mb increase	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
blood creatinine phosphokinase increase	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
blood creatinine decrease	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
blood creatinine increase	7/163 (4.3%)		0/163 (0%)		1/165 (0.6%)
blood glucose increase	2/163 (1.2%)		0/163 (0%)		1/165 (0.6%)
blood pressure increase	0/163 (0%)		1/163 (0.6%)		2/165 (1.2%)
blood urine present	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
c reactive protein increase	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
Musculoskeletal and connective tissue disorders
arthralgia	3/163 (1.8%)		3/163 (1.8%)		3/165 (1.8%)
back pain	3/163 (1.8%)		2/163 (1.2%)		2/165 (1.2%)
fibromyalgia	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
intervertebral disc protrusion	1/163 (0.6%)		0/163 (0%)		2/165 (1.2%)
limb discomfort	1/163 (0.6%)		0/163 (0%)		2/165 (1.2%)
muscle spasms	2/163 (1.2%)		3/163 (1.8%)		4/165 (2.4%)
muscle weakness	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
musculoskeletal chest pain	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
musculoskeletal pain	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
myalgia	3/163 (1.8%)		1/163 (0.6%)		1/165 (0.6%)
neck pain	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
pain in extremity	4/163 (2.5%)		3/163 (1.8%)		1/165 (0.6%)
poly arthritis	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
rotator cuff syndrome	1/163 (0.6%)		0/163 (0%)		2/165 (1.2%)
spinal disorder	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
systemic lupus erythematosus	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
tendonitis	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
gastrointestinal tract adenoma	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
laryngeal papilloma	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
Nervous system disorders
burning sensation	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
cerebrovascular accident	0/163 (0%)		1/163 (0.6%)		1/165 (0.6%)
dizziness	4/163 (2.5%)		1/163 (0.6%)		2/165 (1.2%)
dysaesthesia	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
dysarthria	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
headache	3/163 (1.8%)		12/163 (7.4%)		7/165 (4.2%)
memory impairment	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
migraine	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
neuropathy peripheral	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
paraesthesia	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
sciatica	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
somnolence	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
tension headache	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
Psychiatric disorders
affect lability	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
agitation	0/163 (0%)		0/163 (0%)		2/165 (1.2%)
anger	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
anxiety	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
attention deficit hyperactivity disorder	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
bruxism	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
confusional state	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
depression	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
emotional disorder	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
insomnia	0/163 (0%)		5/163 (3.1%)		1/165 (0.6%)
irritability	0/163 (0%)		1/163 (0.6%)		1/165 (0.6%)
libido increase	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
mental disorder	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
sleep disorder	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
Renal and urinary disorders
azotemia	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
bladder disorder	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
bladder pain	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
contracted bladder	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
dysuria	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
hematuria	3/163 (1.8%)		2/163 (1.2%)		3/165 (1.8%)
leukocyturia	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
micturition urgency	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
nephrolithiasis	2/163 (1.2%)		1/163 (0.6%)		0/165 (0%)
nocturia	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
polyuria	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
stress urinary incontinence	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
urethral caruncle	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
urinary incontinence	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
urinary retention	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
urine odor abnormal	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
Reproductive system and breast disorders
breast cyst	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
breast tenderness	2/163 (1.2%)		2/163 (1.2%)		0/165 (0%)
clitoral engorgement	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
coital bleeding	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
cystocele	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
endometrial thickening	2/163 (1.2%)		1/163 (0.6%)		3/165 (1.8%)
hydrometra	3/163 (1.8%)		1/163 (0.6%)		0/165 (0%)
ovarian cyst	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
pelvic congestion	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
pelvic pain	1/163 (0.6%)		1/163 (0.6%)		2/165 (1.2%)
uterine polyp	1/163 (0.6%)		0/163 (0%)		1/165 (0.6%)
vaginal discharge	2/163 (1.2%)		1/163 (0.6%)		0/165 (0%)
vaginal enlargement	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
vaginal hemorrhage	1/163 (0.6%)		1/163 (0.6%)		1/165 (0.6%)
vaginal lesion	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
vulva cyst	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
vulvovaginal discomfort	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
vulvovaginal pruritus	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
Respiratory, thoracic and mediastinal disorders
asthma	1/163 (0.6%)		1/163 (0.6%)		0/165 (0%)
chronic obstructive pulmonary disease	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
cough	3/163 (1.8%)		2/163 (1.2%)		2/165 (1.2%)
dysphonia	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
nasal congestion	2/163 (1.2%)		2/163 (1.2%)		0/165 (0%)
oropharyngeal pain	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
pleural effusion	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
productive cough	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
pulmonary congestion	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
pulmonary mass	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
reflux laryngitis	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
respiratory failure	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
respiratory tract congestion	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
sinus congestion	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
sleep apnea syndrome	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
throat irritation	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
upper airway cough syndrome	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
wheezing	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
urticaria	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
Skin and subcutaneous tissue disorders
acne	1/163 (0.6%)		3/163 (1.8%)		3/165 (1.8%)
alopecia	2/163 (1.2%)		0/163 (0%)		0/165 (0%)
dermatitis	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
dermatitis atopic	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
dry skin	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
ecchymosis	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
eczema	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
hirsutism	0/163 (0%)		1/163 (0.6%)		3/165 (1.8%)
hyperhidrosis	1/163 (0.6%)		0/163 (0%)		2/165 (1.2%)
photosensitivity reaction	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
pruritus	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
rash	2/163 (1.2%)		0/163 (0%)		1/165 (0.6%)
rash papular	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
rosacea	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
seborrhoea	2/163 (1.2%)		0/163 (0%)		0/165 (0%)
skin exfoliation	1/163 (0.6%)		0/163 (0%)		0/165 (0%)
skin irritation	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
Vascular disorders
aortic aneurysm	0/163 (0%)		0/163 (0%)		1/165 (0.6%)
flushing	0/163 (0%)		1/163 (0.6%)		0/165 (0%)
hot flush	1/163 (0.6%)		4/163 (2.5%)		0/165 (0%)
hypertension	3/163 (1.8%)		6/163 (3.7%)		2/165 (1.2%)
hypertensive crisis	0/163 (0%)		0/163 (0%)		1/165 (0.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.