Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus

Study Overview
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Brief Summary
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The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.

Official Title
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Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus: A 40 Week Randomized, Double Blind, Placebo Controlled, Follow-Up to Protocol 15-50310.

Conditions
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Atrophy, Vaginal Diseases

Intervention / Treatment
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* Drug: Ospemifene (Dose 1)
* Drug: Ospemifene (Dose 2)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310 Had an intact uterus Met the inclusion and exclusion criteria for Protocol 15-50310 Had completed Protocol 15-50310 Exclusion Criteria: Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310 Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br> | Drug: Ospemifene (Dose 1)<br> <br> |
| Experimental: Treatment Group 2<br> | Drug: Ospemifene (Dose 2)<br> <br> |
| Placebo Comparator: Treatment Group 3<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Week 20 (Phone Contact) to Week 56 (Visit 7) | 
| Assessment of Cervical Pap Smear Samples | Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells. | Week 52 (Visit 6) | 
| Assessment of Endometrial Biopsy | Assessments were based on Blaustein's classification. | Week 52 (Visit 6) | 
| Mean Percent Change From Baseline in Serum Lipids |  | Baseline to Week 26 (Visit 5) | 
| Mean Percent Change From Baseline in Serum Lipids |  | Baseline to Week 52 (Visit 6) | 
| Mean Change in Blood Chemistry Parameters |  | Baseline to Week 26 (Visit 5) | 
| Mean Change in Blood Chemistry Parameters |  | Baseline to Week 52 (Visit 6) | 
| Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU) | Mean change in endometrial thickness from baseline | Baseline to Week 26 (Visit 5) | 
| Assessment of Endometrial Safety With a TVU | Mean change in endometrial thickness from baseline | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Visual Evaluation of the Vagina | Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe). | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Visual Evaluation of the Vagina | Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe). | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Estradiol (E2) Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Luteinizing Hormone (LH) Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Follicle Stimulating Hormone (FSH) Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Testosterone (Total) Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Testosterone (Free) Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in E2 Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in LH Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in FSH Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in SHBG Levels |  | Baseline to Week 52 (Visit 6) | 
| Assessment of Mammography | Mammography was done for the detection of characteristic masses and microcalcifications in the breast. | Week 52 (Visit 6) | 
| Change From Baseline in Testosterone (Total) Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Testosterone (Free) Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Antithrombin Antigen, P Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Fibrinogen Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Protein C Ag, P Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Protein S Ag (Free), P Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Thromboplastin Time |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Antithrombin Antigen, P Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Fibrinogen Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Protein C Ag, P Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Protein S Ag (Free), P Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Thromboplastin Time |  | Baseline to Week 52 (Visit 6) | 
| Assessment of Breast Palpation | Breast palpation was done by the investigator to assess abnormalities in the breast. | Week 26 (Visit 5) | 
| Assessment of Breast Palpation | Breast palpation was done by the investigator to assess abnormalities in the breast. | Week 52 (Visit 6) | 
| Assessment of Hematology Tests | Change from baseline | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Erythrocyte (RBC) Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Hemogobin Levels |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Hematocrit Levels |  | Baseline to Week 26 (Visit 5) | 
| Assessment of Hematology Test Values | Change from baseline | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Erythrocyte (RBC) Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Hemoglobin Levels |  | Baseine to Week 52 (Visit 6) | 
| Change From Baseline in Hematocrit Levels |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in pH of Urine |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Specific Gravtiy of Urine |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in pH of Urine |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Specific Gravity of Urine |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Systolic Blood Pressure (SBP) |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Diastolic Blood Pressure (DBP) |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Pulse Rate |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in Weight |  | Baseline to Week 26 (Visit 5) | 
| Change From Baseline in BMI |  | Baseline to Week 26 | 
| Change From Baseline in SBP |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in DBP |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Pulse Rate |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in Weight |  | Baseline to Week 52 (Visit 6) | 
| Change From Baseline in BMI |  | Baseline to Week 52 (Visit 6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopausal symptoms, Urogenital atrophy, Vulvar and vaginal atrophy in menopausal women, Vaginal atrophy