A Clinical Study to Evaluate the Efficacy and Safety of O... | NCT00630539

Status Module

Name	Class
Hormos Medical	INDUSTRY
QuatRx Pharmaceuticals	INDUSTRY

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects on placebo	Placebo Comparator	Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks	Drug: Placebo
Subjects on ospemifene 5 mg/day	Experimental	Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks	Drug: Ospemifene 5 mg
Subjects on ospemifene 15 mg/day	Experimental	Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks	Drug: Ospemifene 15 mg
Subjects on ospemifene 30 mg/day	Experimental	Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks	Drug: Ospemifene 30 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).	Subjects on placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear		12 weeks
Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear		12 weeks
Mean Change From Baseline in Vaginal pH		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Visual Evaluation of Vagina (by Gynecological Examination)		Screening & Week 12
Mean Change From Baseline in Vaginal pH		Week 4
Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index

Eligibility Module

Name	Affiliation	Role
Shionogi Clinical Trials Administrator Clinical Support Help Line	Shionogi	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
FG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
BG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
BG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
BG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00034 BG00133 BG00229 BG00330 BG004126

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.8± 6.0 BG00161.5± 5.6 BG00263.4± 7.1 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00034 BG00133 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Participants

Title	Measurements
	BG00034 BG00133 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00069.6± 10.1 BG00166.5± 10.6 BG002

Height

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG0001.609± 0.049 BG0011.636± .051 BG002

BMI

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00026.89± 3.95 BG00124.78± 3.44 BG002

Alcohol

Mean

Standard Deviation

drinks/week

Title

Denominators

Categories

Title	Measurements
	BG0000.9± 1.9 BG0011.8± 2.4 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear

ITT

Posted

Mean

Standard Deviation

percentage of parabasal cells

12 weeks

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts
Participants	OG00034 OG00133 OG00229 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-3.0± 30.2 OG001-2.8± 33.2 OG002-24.1± 36.7 OG003

Primary

Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear

ITT

Posted

Mean

Standard Deviation

percentage of superficial cells

12 weeks

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts

Primary

Mean Change From Baseline in Vaginal pH

ITT

Posted

Mean

Standard Deviation

12 weeks

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts
Participants

Secondary

Visual Evaluation of Vagina (by Gynecological Examination)

ITT

Posted

Number

percentage of subjects

Screening & Week 12

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Placebo (Week 12)	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 5 mg/Day (Week 12)	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG004	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks

Secondary

Mean Change From Baseline in Vaginal pH

ITT

Posted

Mean

Standard Deviation

Week 4

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts
Participants

Secondary

Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index

ITT

Posted

Mean

Standard Deviation

percentage of superficial cells

Week 4

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts

Secondary

Mean Change From Baseline in Estradiol Levels

ITT

Posted

Mean

Standard Deviation

nmol/L

Week 12

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts
Participants

Secondary

Mean Change From Baseline in Luteinizing Hormone Levels

ITT

Posted

Mean

Standard Deviation

U/L

Week 12

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts
Participants

Secondary

Mean Change From Baseline in Follicle Stimulating Hormone Levels

ITT

Posted

Mean

Standard Deviation

U/L

Week 12

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts
Participants

Secondary

Mean Change From Baseline in Sex Hormone Binding Globulin Levels

ITT

Posted

Mean

Standard Deviation

nmol/L

Week 12

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts
Participants

Secondary

Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index

ITT

Posted

Mean

Standard Deviation

percentage of parabasal cells

Week 4

ID	Title	Description
OG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
OG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
OG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
OG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Subjects on Placebo	Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks	1	34	25	34
EG001	Subjects on Ospemifene 5 mg/Day	Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks	0	33	7	33
EG002	Subjects on Ospemifene 15 mg/Day	Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks	0	29	13	29
EG003	Subjects on Ospemifene 30 mg/Day	Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks	0	30	16	30

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Influenza	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG0032 affected30 at risk
Respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0011 affected33 at risk EG0020 affected29 at risk EG003
Vaginitis bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0012 affected33 at risk EG0020 affected29 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected34 at risk EG0011 affected33 at risk EG0025 affected29 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Genital discharge	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected34 at risk EG0010 affected33 at risk EG0022 affected29 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected34 at risk EG0010 affected33 at risk EG0020 affected29 at risk EG003
Vulvovaginal discomfort	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0010 affected33 at risk EG0021 affected29 at risk EG003
Hot flush	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected34 at risk EG0013 affected33 at risk EG0023 affected29 at risk EG003

ID	Term
D001284	Atrophy
D014623	Vaginal Diseases

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases