Trial Outcomes & Findings for Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity (NCT NCT00729469)

NCT ID: NCT00729469

Last Updated: 2018-05-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 919 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-05-18

Participant Flow

First patient was screened on August 04, 2008 and last patient completed on July 30, 2009

Subjects reporting moderate to severe VVA symptoms of vaginal dryness or vaginal pain associated with sexual activity as the most bothersome symptom (MBS) at the initial screening visit were allowed to continue in the screening phase of the study. Each subject entered 1 of 2 strata based on their self-reported moderate to severe MBS

Participant milestones

Measure	Subjects on Placebo Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Overall Study STARTED	456	463
Overall Study COMPLETED	403	416
Overall Study NOT COMPLETED	53	47

Reasons for withdrawal

Measure	Subjects on Placebo Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Overall Study Adverse Event	14	25
Overall Study Lost to Follow-up	9	9
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	19	8
Overall Study Other-Not mentioned	9	4

Baseline Characteristics

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

Baseline characteristics by cohort

Measure	Subjects on Placebo n=456 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=463 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Total n=919 Participants Total of all reporting groups
Age, Continuous	58.5 Years STANDARD_DEVIATION 6.39 • n=5 Participants	58.7 Years STANDARD_DEVIATION 6.56 • n=7 Participants	58.6 Years STANDARD_DEVIATION 6.47 • n=5 Participants
Age, Customized <45	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Age, Customized 45-54	106 participants n=5 Participants	113 participants n=7 Participants	219 participants n=5 Participants
Age, Customized 55-64	266 participants n=5 Participants	260 participants n=7 Participants	526 participants n=5 Participants
Age, Customized >=65	77 participants n=5 Participants	82 participants n=7 Participants	159 participants n=5 Participants
Sex: Female, Male Female	456 Participants n=5 Participants	463 Participants n=7 Participants	919 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	396 participants n=5 Participants	409 participants n=7 Participants	805 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	35 participants n=5 Participants	28 participants n=7 Participants	63 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	8 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Other	22 participants n=5 Participants	16 participants n=7 Participants	38 participants n=5 Participants
Height	162.6 cm STANDARD_DEVIATION 6.39 • n=5 Participants	162.3 cm STANDARD_DEVIATION 6.34 • n=7 Participants	162.5 cm STANDARD_DEVIATION 6.36 • n=5 Participants
Weight	69.38 kg STANDARD_DEVIATION 12.38 • n=5 Participants	68.98 kg STANDARD_DEVIATION 12.38 • n=7 Participants	69.18 kg STANDARD_DEVIATION 12.37 • n=5 Participants
BMI	26.21 kg/m^2 STANDARD_DEVIATION 4.32 • n=5 Participants	26.16 kg/m^2 STANDARD_DEVIATION 4.31 • n=7 Participants	26.18 kg/m^2 STANDARD_DEVIATION 4.31 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT; LOCF

Outcome measures

Measure	Subjects on Placebo n=154 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=160 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)	-3.7 percentage of parabasal cells Standard Deviation 29.97	-31.7 percentage of parabasal cells Standard Deviation 37.25

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT; LOCF

Outcome measures

Measure	Subjects on Placebo n=154 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=160 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)	3.3 percentage of superficial cells Standard Deviation 9.02 • Interval -11.0 to 57.0	12.4 percentage of superficial cells Standard Deviation 15.36 • Interval -4.0 to 65.0

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT; LOCF

Outcome measures

Measure	Subjects on Placebo n=154 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=160 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)	-0.24 pH Standard Deviation 0.800	-0.92 pH Standard Deviation 1.100

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT; LOCF

Outcome measures

Measure	Subjects on Placebo n=154 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=160 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) -3 (Sev. to none)	14 participants	23 participants
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) -2 (Sev. to mild, or mod. to none)	39 participants	51 participants
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) -1 (Sev. to mod., mod.to mild, or mild to none)	52 participants	39 participants
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) 0 (No change)	44 participants	44 participants
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) 1 (None to mild, mild to mod., or mod. to sev.)	5 participants	3 participants

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT; LOCF

Outcome measures

Measure	Subjects on Placebo n=302 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=303 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)	0.0 percentage of parabasal cells Standard Deviation 30.00	-40.2 percentage of parabasal cells Standard Deviation 38.80

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT; LOCF

Outcome measures

Measure	Subjects on Placebo n=302 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=303 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)	1.7 percentage of superficial cells Standard Deviation 6.88	12.3 percentage of superficial cells Standard Deviation 14.77

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT; LOCF

Outcome measures

Measure	Subjects on Placebo n=302 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=303 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)	-0.07 pH Standard Deviation 0.814	-0.94 pH Standard Deviation 1.016

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT; LOCF

Outcome measures

Measure	Subjects on Placebo n=302 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=303 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) -3 (Sev. to none)	47 participants	67 participants
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) -2 (Sev. to mild, or mod. to none)	70 participants	93 participants
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) -1 (Sev. to mod., mod.to mild, or mild to none)	76 participants	82 participants
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) 0 (No change)	102 participants	55 participants
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) 1 (None to mild, mild to mod., or mod. to sev.)	7 participants	6 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT

Outcome measures

Measure	Subjects on Placebo n=154 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=160 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)	-2.8 percentage of parabasal cells Standard Deviation 2.18	-31.2 percentage of parabasal cells Standard Deviation 2.15

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT

Outcome measures

Measure	Subjects on Placebo n=154 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=160 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)	3.6 percentage of superficial cells Standard Deviation 1.07	12.7 percentage of superficial cells Standard Deviation 1.05

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT

Outcome measures

Measure	Subjects on Placebo n=154 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=160 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)	-0.21 pH Standard Deviation 0.884	-0.81 pH Standard Deviation 0.962

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal dryness associated with sexual activity (dryness strata) was assessed in 152 subjects in the placebo group and 154 subjects in the ospemifene 60 mg/day group.

Outcome measures

Measure	Subjects on Placebo n=152 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=154 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) -3 (Sev. to None)	9 participants	11 participants
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) -2 (Sev. to Mild, or Mod. to None)	25 participants	31 participants
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) -1 (Sev. to Mod., Mod. to Mild, or Mild to None)	57 participants	67 participants
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) 0 (No change)	60 participants	40 participants
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) 1 (None to Mild, Mild to Mod., or Mod. to Sev.)	1 participants	5 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT

Outcome measures

Measure	Subjects on Placebo n=302 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=303 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)	-0.15 pH Standard Deviation 0.821	-0.82 pH Standard Deviation 0.979

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal pain associated with sexual activity (dyspareunia strata) was assessed in 287 subjects in the placebo group and 295 subjects in the ospemifene 60 mg/day group.

Outcome measures

Measure	Subjects on Placebo n=287 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=295 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) -3 (Sev. to None)	34 participants	39 participants
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) -2 (Sev. to Mild, or Mod. to None)	64 participants	72 participants
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) -1 (Sev. to Mod., Mod. to Mild, or Mild to None)	84 participants	97 participants
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) 0 (No change)	95 participants	78 participants
Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) 1 (None to Mild, Mild to Mod., or Mod. to Sev.)	10 participants	9 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT

Outcome measures

Measure	Subjects on Placebo n=302 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=303 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)	-0.8 percentage of parabasal cells Standard Deviation 1.59	-37.8 percentage of parabasal cells Standard Deviation 1.54

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT

Outcome measures

Measure	Subjects on Placebo n=302 Participants Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=303 Participants Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)	1.9 percentage of superficial cells Standard Deviation 0.69	13.0 percentage of superficial cells Standard Deviation 0.67

Adverse Events

Subjects on Placebo

Serious events: 7 serious events

Other events: 102 other events

Deaths: 0 deaths

Subjects on Ospemifene 60 mg/Day

Serious events: 6 serious events

Other events: 153 other events

Deaths: 0 deaths

Serious adverse events

Measure	Subjects on Placebo n=456 participants at risk Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=463 participants at risk Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Cardiac disorders Palpitations	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Endocrine disorders Autoimmune Thyroiditis	0.00% 0/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.22% 1/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Endocrine disorders Hypoparathyroidism	0.00% 0/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.22% 1/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Gastrointestinal disorders Diverticulitis	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.22% 1/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
General disorders Non-Cardiac Chest Pain	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Infections and infestations Appendicitis	0.00% 0/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.43% 2/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Infections and infestations Peridiverticular Abscess	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Infections and infestations Pneumonia	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Nervous system disorders Intracranial Aneurysm	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.22% 1/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Nervous system disorders Migraine	0.00% 0/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.22% 1/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Nervous system disorders Cerebrovascular Accident	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Psychiatric disorders Bipolar Disorder	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Psychiatric disorders Suicide Attempt	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Renal and urinary disorders Bladder Prolapse	0.22% 1/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.00% 0/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Vascular disorders Deep Vein Thrombosis	0.00% 0/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	0.22% 1/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information

Other adverse events

Measure	Subjects on Placebo n=456 participants at risk Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.	Subjects on Ospemifene 60 mg/Day n=463 participants at risk Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Infections and infestations Urinary Tract Infection	5.0% 23/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	8.0% 37/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Infections and infestations Nasopharyngitis	3.5% 16/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	4.3% 20/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Infections and infestations Vulvovaginal Candidiasis	0.44% 2/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	3.9% 18/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Infections and infestations Vulvovaginal Mycotic Infection	0.44% 2/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	3.7% 17/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Infections and infestations Upper Respiratory Tract Infection	4.6% 21/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	3.2% 15/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Infections and infestations Sinusitis	5.5% 25/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	2.4% 11/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Nervous system disorders Headache	4.6% 21/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	3.5% 16/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Reproductive system and breast disorders Vaginal Discharge	0.66% 3/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	4.5% 21/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Vascular disorders Hot Flush	3.3% 15/456 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information	6.9% 32/463 • 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information

Additional Information

Shionogi Clinical Trials Administrator

Shionogi Inc.

Phone: 800-849-9707

Email: shionogiclintrialsadmin@shionogi.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER