Back to results

Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

Primary Purpose

Atrophy, Vaginal Diseases

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Ospemifene 60Mg Oral Tablet

About this trial

This is an interventional treatment trial for Atrophy focused on measuring Menopausal symptoms, Vulvar and vaginal atrophy in menopausal women, Vaginal atrophy, Urogenital atrophy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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
Did not have a uterus
Met the inclusion and exclusion criteria for Protocol 15-50310
Had completed Protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for Protocol 15-50310
Provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ospemifene 60 mg Oral Tablet

Arm Description

Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs)

Change From Baseline in Serum Lipid Levels at Visit 2

Change From Baseline in Serum Lipid Levels at Visit 3

Change From Baseline in Blood Pressure at Visit 2

Systolic blood pressure (SBP), diastolic blood pressure (DBP)

Change From Baseline in Pulse Rate at Visit 2

Change From Baseline in Weight at Visit 2

Change From Baseline in Body Mass Index (BMI) at Visit 2

Change From Baseline in Blood Pressure at Visit 3

Change From Baseline in Pulse Rate at Visit 3

Change From Baseline in Weight at Visit 3

Change From Baseline in BMI at Visit 3

Change From Baseline in Visual Evaluation of Vagina at Visit 2

Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)

Change From Baseline in Visual Evaluation of Vagina at Visit 3

Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)

Assessment of Cervical Pap Smear Samples (if Cervix is Intact)

Cervical Pap smear samples are 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.

Assessment of Breast Palpation at Visit 2

Breast palpation was used to assess breast abnormalities.

Assessment of Breast Palpation at Visit 3

Breast palpation was used to assess breast abnormalities.

Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2

Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2

Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2

Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3

Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3

Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3

Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2

Change From Baseline in Erythrocyte Levels at Visit 2

Change From Baseline in Hemoglobin Levels at Visit 2

Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2

Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2

Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3

Change From Baseline in Erythrocyte Levels at Visit 3

Change From Baseline in Hemoglobin Levels at Visit 3

Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3

Change From Baseline in MCV and MPV at Visit 3

Change From Baseline in Albumin and Total Protein Levels at Visit 2

Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2

Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2

Change From Baseline in Albumin and Total Protein Levels at Visit 3

Change From Baseline in ALT, AST and CK Levels at Visit 3

Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3

Change From Baseline in pH of Urine at Visit 2

Change From Baseline in Specific Gravity of Urine at Visit 2

Change From Baseline in pH of Urine at Visit 3

Change From Baseline in Specific Gravity of Urine at Visit 3

Change From Baseline in Estradiol (E2) Levels at Visit 2

Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2

Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2

Change From Baseline in Testosterone Levels at Visit 2

Change From Baseline in E2 Levels at Visit 3

Change From Baseline in FSH and LH Levels at Visit 3

Change From Baseline in SHBG Levels at Visit 3

Change From Baseline in Testosterone Levels at Visit 3

Secondary Outcome Measures

Full Information

NCT ID

NCT01586364

First Posted

April 18, 2012

Last Updated

April 19, 2018

Sponsor

Shionogi

Collaborators

QuatRx Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01586364

Brief Title

Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

Official Title

Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus: A 52-Week Open-Label Follow-Up to Protocol 15-50310

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

May 8, 2006 (Actual)

Primary Completion Date

November 21, 2008 (Actual)

Study Completion Date

December 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shionogi

Collaborators

QuatRx Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrophy, Vaginal Diseases

Keywords

Menopausal symptoms, Vulvar and vaginal atrophy in menopausal women, Vaginal atrophy, Urogenital atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

301 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ospemifene 60 mg Oral Tablet

Arm Type

Experimental

Arm Description

Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Ospemifene 60Mg Oral Tablet

Other Intervention Name(s)

Osphena®

Primary Outcome Measure Information:

Title

Incidence of Adverse Events (AEs)

Time Frame

Week 13 (Phone Contact) to Week 56 (Visit 4)

Title

Change From Baseline in Serum Lipid Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Serum Lipid Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Blood Pressure at Visit 2

Description

Systolic blood pressure (SBP), diastolic blood pressure (DBP)

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Pulse Rate at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Weight at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Body Mass Index (BMI) at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Blood Pressure at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Pulse Rate at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Weight at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in BMI at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Visual Evaluation of Vagina at Visit 2

Description

Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Visual Evaluation of Vagina at Visit 3

Description

Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)

Time Frame

Baseline to Week 52 (Visit 3)

Title

Assessment of Cervical Pap Smear Samples (if Cervix is Intact)

Description

Time Frame

Week 52 (Visit 3)

Title

Assessment of Breast Palpation at Visit 2

Description

Breast palpation was used to assess breast abnormalities.

Time Frame

Week 26 (Visit 2)

Title

Assessment of Breast Palpation at Visit 3

Description

Breast palpation was used to assess breast abnormalities.

Time Frame

Week 52 (Visit 3)

Title

Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Erythrocyte Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Hemoglobin Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Erythrocyte Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Hemoglobin Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in MCV and MPV at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Albumin and Total Protein Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Albumin and Total Protein Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in ALT, AST and CK Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in pH of Urine at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Specific Gravity of Urine at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in pH of Urine at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Specific Gravity of Urine at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Estradiol (E2) Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in Testosterone Levels at Visit 2

Time Frame

Baseline to Week 26 (Visit 2)

Title

Change From Baseline in E2 Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in FSH and LH Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in SHBG Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

Title

Change From Baseline in Testosterone Levels at Visit 3

Time Frame

Baseline to Week 52 (Visit 3)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Did not have a uterus Met the inclusion and exclusion criteria for Protocol 15-50310 Had completed Protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for Protocol 15-50310 Provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits 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

12. IPD Sharing Statement

Learn more about this trial

Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

We'll reach out to this number within 24 hrs