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A Clinical Study to Evaluate the Safety of Ospemifene

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ClinicalTrials.gov Identifier: NCT00566982
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : June 28, 2013
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Hormos Medical
QuatRx Pharmaceuticals
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Atrophy
Vaginal Diseases
Interventions Drug: Ospemifene 60 mg
Drug: Placebo
Enrollment 426
Recruitment Details This was a multicenter study conducted at 23 centers in Belgium, Denmark, Finland, and Sweden. First subject was screened on Nov. 26, 2007 and last subjected completed the study on June 26, 2009
Pre-assignment Details  
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Hide Arm/Group Description Placebo was taken orally, once daily, in the morning, with food for 52 weeks. Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Period Title: Overall Study
Started 63 363
Completed 55 294
Not Completed 8 69
Reason Not Completed
Adverse Event             6             48
Withdrawal by Subject             1             14
Protocol Violation             1             4
Lost to Follow-up             0             1
Other-family problems & doctor's request             0             2
Arm/Group Title Subjects on Ospemifene 60 mg/Day (Baseline) Subjects on Placebo (Baseline) Total
Hide Arm/Group Description Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks. Placebo was taken orally, once daily, in the morning, with food for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 363 63 426
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 363 participants 63 participants 426 participants
61.7  (6.16) 62.9  (6.47) 62.3  (6.32)
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 363 participants 63 participants 426 participants
61.7
(49 to 78)
62.9
(50 to 79)
62.3
(49 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 363 participants 63 participants 426 participants
Female
363
 100.0%
63
 100.0%
426
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 363 participants 63 participants 426 participants
Caucasian 361 63 424
Black 1 0 1
Asian 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 363 participants 63 participants 426 participants
Belgium 101 18 119
Denmark 56 9 65
Finland 177 31 208
Sweden 29 5 34
Alcohol  
Mean (Standard Deviation)
Unit of measure:  Drinks/week
Number Analyzed 363 participants 63 participants 426 participants
2.4  (3.40) 2.3  (3.26) 2.35  (3.33)
Alcohol  
Mean (Full Range)
Unit of measure:  Drinks/week
Number Analyzed 363 participants 63 participants 426 participants
2.4
(0 to 14)
2.3
(0 to 14)
2.35
(0 to 14)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 363 participants 63 participants 426 participants
24.65  (2.916) 24.11  (2.867) 24.38  (2.892)
BMI  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 363 participants 63 participants 426 participants
24.65
(17.4 to 31.2)
24.11
(17.7 to 29.7)
24.38
(17.4 to 31.2)
1.Primary Outcome
Title Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Hide Arm/Group Description:
Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Overall Number of Participants Analyzed 63 363
Mean (Standard Deviation)
Unit of Measure: percentage of parabasal cells
5.0  (27.86) -46.0  (41.96)
2.Primary Outcome
Title Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Hide Arm/Group Description:
Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Overall Number of Participants Analyzed 63 363
Mean (Standard Deviation)
Unit of Measure: percentage of superficial cells
1.0  (4.36) 10.3  (12.53)
3.Primary Outcome
Title Mean Change From Baseline in Vaginal pH
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Hide Arm/Group Description:
Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Overall Number of Participants Analyzed 63 363
Mean (Standard Deviation)
Unit of Measure: pH
-0.16  (0.945) -1.21  (0.912)
4.Secondary Outcome
Title Change From Baseline in Estradiol Levels
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Hide Arm/Group Description:
Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Overall Number of Participants Analyzed 63 363
Mean (Standard Deviation)
Unit of Measure: nmol/L
0.004  (0.0120) 0.004  (0.0145)
5.Secondary Outcome
Title Change From Baseline in Luteinizing Hormone Levels
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Hide Arm/Group Description:
Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Overall Number of Participants Analyzed 63 363
Mean (Standard Deviation)
Unit of Measure: U/L
-0.88  (7.738) -3.16  (8.127)
6.Secondary Outcome
Title Change From Baseline in Follicle Stimulating Hormone Levels
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Hide Arm/Group Description:
Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Overall Number of Participants Analyzed 63 363
Mean (Standard Deviation)
Unit of Measure: U/L
-7.63  (17.083) -19.69  (18.977)
7.Secondary Outcome
Title Change From Baseline in Sex Hormone Binding Globulin Levels
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Hide Arm/Group Description:
Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Overall Number of Participants Analyzed 63 363
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.8  (15.41) 31.0  (27.16)
8.Secondary Outcome
Title Visual Evaluation of the Vagina (Baseline & Week 52)
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Placebo (Week 52) Subjects on Ospemifene 60 mg/Day (Baseline) Subjects on Ospemifene 60 mg/Day (Week 52)
Hide Arm/Group Description:
Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
Overall Number of Participants Analyzed 63 63 363 363
Measure Type: Number
Unit of Measure: participants
Friability-None 10 20 74 241
Friability-Mild 28 12 118 35
Friability-Moderate 14 21 125 17
Friability-Severe 11 3 46 4
Pallor-None 7 13 47 232
Pallor-Mild 28 21 147 53
Pallor-Moderate 23 17 146 11
Pallor-Severe 5 5 23 1
Petechiae-None 24 22 134 243
Petechiae-Mild 18 12 110 39
Petechiae-Moderate 19 17 95 12
Petechiae-Severe 2 5 24 3
Vaginal dryness in the mucosa-None 10 18 46 242
Vaginal dryness in the mucosa-Mild 14 17 120 39
Vaginal dryness in the mucosa-Moderate 32 16 150 15
Vaginal dryness in the mucosa-Severe 7 5 47 1
Vaginal redness in the mucosa-None 13 17 76 219
Vaginal redness in the mucosa-Mild 31 21 164 52
Vaginal redness in the mucosa-Moderate 14 15 101 22
Vaginal redness in the mucosa-Severe 5 3 21 4
Time Frame 16 Weeks; From the signing of the informed consent form to the last safety evaluation (Week 12)
Adverse Event Reporting Description Safety data were reported in the safety population, which included all treated subjects according to the treatment they actually received.
 
Arm/Group Title Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Hide Arm/Group Description Placebo was taken orally, once daily, in the morning, with food for 52 weeks. Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
All-Cause Mortality
Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/62 (6.45%)   18/364 (4.95%) 
Blood and lymphatic system disorders     
Multiple myeloma  1  0/62 (0.00%)  1/364 (0.27%) 
Cardiac disorders     
Tachycardia  1  1/62 (1.61%)  0/364 (0.00%) 
Mitral valve incompetence  1  1/62 (1.61%)  0/364 (0.00%) 
Gastrointestinal disorders     
Nausea  1  1/62 (1.61%)  0/364 (0.00%) 
Diverticulitis  1  0/62 (0.00%)  1/364 (0.27%) 
Hiatus hernia  1  0/62 (0.00%)  1/364 (0.27%) 
Gastrointestinal inflammation  1  0/62 (0.00%)  1/364 (0.27%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/62 (0.00%)  1/364 (0.27%) 
Infections and infestations     
Urinary tract infection  1  1/62 (1.61%)  0/364 (0.00%) 
Injury, poisoning and procedural complications     
Patella fracture  1  1/62 (1.61%)  0/364 (0.00%) 
Lower limb fracture  1  0/62 (0.00%)  1/364 (0.27%) 
Road traffic accident  1  0/62 (0.00%)  1/364 (0.27%) 
Burns third degree  1  0/62 (0.00%)  1/364 (0.27%) 
Musculoskeletal and connective tissue disorders     
Seronegative Arthritis  1  1/62 (1.61%)  0/364 (0.00%) 
Osteoarthritis  1  0/62 (0.00%)  1/364 (0.27%) 
Spinal column stenosis  1  0/62 (0.00%)  1/364 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian cyst  1  0/62 (0.00%)  1/364 (0.27%) 
Mesothelioma malignant  1  0/62 (0.00%)  1/364 (0.27%) 
Nervous system disorders     
Dizziness  1  1/62 (1.61%)  0/364 (0.00%) 
Cerebral haemorrhage  1  0/62 (0.00%)  1/364 (0.27%) 
Cerebrovascular accident  1  0/62 (0.00%)  1/364 (0.27%) 
Global amnesia  1  0/62 (0.00%)  1/364 (0.27%) 
Renal and urinary disorders     
Calculus urinary  1  1/62 (1.61%)  0/364 (0.00%) 
Reproductive system and breast disorders     
Endometrial hyperplasia  1  0/62 (0.00%)  1/364 (0.27%) 
Surgical and medical procedures     
Cardiac ablation  1  0/62 (0.00%)  1/364 (0.27%) 
Breast cosmetic surgery  1  0/62 (0.00%)  1/364 (0.27%) 
Carpel tunnel decompression  1  0/62 (0.00%)  1/364 (0.27%) 
Blepharoplasty  1  0/62 (0.00%)  1/364 (0.27%) 
Arthrodesis  1  0/62 (0.00%)  1/364 (0.27%) 
Vascular disorders     
Deep vein thrombosis  1  0/62 (0.00%)  1/364 (0.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Subjects on Placebo (Baseline) Subjects on Ospemifene 60 mg/Day (Baseline)
Affected / at Risk (%) Affected / at Risk (%)
Total   37/62 (59.68%)   252/364 (69.23%) 
Gastrointestinal disorders     
Diarrhoea  1  1/62 (1.61%)  15/364 (4.12%) 
Abdominal Pain Lower  1  2/62 (3.23%)  10/364 (2.75%) 
Nausea  1  2/62 (3.23%)  10/364 (2.75%) 
Abdominal Pain  1  2/62 (3.23%)  5/364 (1.37%) 
Abdominal Pain Upper  1  4/62 (6.45%)  3/364 (0.82%) 
General disorders     
Influenza Like Illness  1  4/62 (6.45%)  14/364 (3.85%) 
Infections and infestations     
Nasopharyngitis  1  4/62 (6.45%)  36/364 (9.89%) 
Vulvovaginal Candidiasis  1  1/62 (1.61%)  27/364 (7.42%) 
Urinary Tract Infection  1  7/62 (11.29%)  20/364 (5.49%) 
Cystitis  1  0/62 (0.00%)  18/364 (4.95%) 
Urinary Tract Infection Bacterial  1  6/62 (9.68%)  16/364 (4.40%) 
Bronchitis  1  1/62 (1.61%)  15/364 (4.12%) 
Sinusitis  1  0/62 (0.00%)  14/364 (3.85%) 
Gastroenteritis  1  2/62 (3.23%)  8/364 (2.20%) 
Urinary Tract Infection Staphylococcal  1  2/62 (3.23%)  2/364 (0.55%) 
Asymptomatic Bacteriuria  1  2/62 (3.23%)  1/364 (0.27%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  4/62 (6.45%)  6/364 (1.65%) 
Musculoskeletal and connective tissue disorders     
Muscle Spasms  1  4/62 (6.45%)  31/364 (8.52%) 
Back Pain  1  2/62 (3.23%)  24/364 (6.59%) 
Arthralgia  1  3/62 (4.84%)  14/364 (3.85%) 
Pain In Extremity  1  0/62 (0.00%)  12/364 (3.30%) 
Tendonitis  1  2/62 (3.23%)  1/364 (0.27%) 
Nervous system disorders     
Headache  1  6/62 (9.68%)  33/364 (9.07%) 
Psychiatric disorders     
Insomnia  1  0/62 (0.00%)  19/364 (5.22%) 
Reproductive system and breast disorders     
Vaginal Discharge  1  0/62 (0.00%)  20/364 (5.49%) 
Vulvovaginal Dryness  1  1/62 (1.61%)  12/364 (3.30%) 
Genital Discharge  1  1/62 (1.61%)  11/364 (3.02%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  5/62 (8.06%)  22/364 (6.04%) 
Vascular disorders     
Hot Flush  1  4/62 (6.45%)  46/364 (12.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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.
Results Point of Contact
Name/Title: Shionogi Clinical Trials Administrator
Organization: Shionogi Inc.
Phone: 800-849-9707
Responsible Party: Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier: NCT00566982     History of Changes
Other Study ID Numbers: 15-50718
First Submitted: November 30, 2007
First Posted: December 4, 2007
Results First Submitted: March 19, 2013
Results First Posted: June 28, 2013
Last Update Posted: May 18, 2018