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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

Primary Purpose

Atrophy, Vaginal Diseases

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Ospemifene (Dose 1)

Ospemifene (Dose 2)

Placebo

About this trial

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group 1

Treatment Group 2

Treatment Group 3

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs)

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.

Assessment of Endometrial Biopsy

Assessments were based on Blaustein's classification.

Mean Percent Change From Baseline in Serum Lipids

Mean Change in Blood Chemistry Parameters

Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)

Mean change in endometrial thickness from baseline

Assessment of Endometrial Safety With a TVU

Mean change in endometrial thickness from baseline

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).

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).

Change From Baseline in Estradiol (E2) Levels

Change From Baseline in Luteinizing Hormone (LH) Levels

Change From Baseline in Follicle Stimulating Hormone (FSH) Levels

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

Change From Baseline in Testosterone (Total) Levels

Change From Baseline in Testosterone (Free) Levels

Change From Baseline in E2 Levels

Change From Baseline in LH Levels

Change From Baseline in FSH Levels

Change From Baseline in SHBG Levels

Assessment of Mammography

Mammography was done for the detection of characteristic masses and microcalcifications in the breast.

Change From Baseline in Testosterone (Total) Levels

Change From Baseline in Testosterone (Free) Levels

Change From Baseline in Antithrombin Antigen, P Levels

Change From Baseline in Fibrinogen Levels

Change From Baseline in Protein C Ag, P Levels

Change From Baseline in Protein S Ag (Free), P Levels

Change From Baseline in Thromboplastin Time

Change From Baseline in Antithrombin Antigen, P Levels

Change From Baseline in Fibrinogen Levels

Change From Baseline in Protein C Ag, P Levels

Change From Baseline in Protein S Ag (Free), P Levels

Change From Baseline in Thromboplastin Time

Assessment of Breast Palpation

Breast palpation was done by the investigator to assess abnormalities in the breast.

Assessment of Breast Palpation

Breast palpation was done by the investigator to assess abnormalities in the breast.

Assessment of Hematology Tests

Change from baseline

Change From Baseline in Erythrocyte (RBC) Levels

Change From Baseline in Hemogobin Levels

Change From Baseline in Hematocrit Levels

Assessment of Hematology Test Values

Change from baseline

Change From Baseline in Erythrocyte (RBC) Levels

Change From Baseline in Hemoglobin Levels

Change From Baseline in Hematocrit Levels

Change From Baseline in pH of Urine

Change From Baseline in Specific Gravtiy of Urine

Change From Baseline in pH of Urine

Change From Baseline in Specific Gravity of Urine

Change From Baseline in Systolic Blood Pressure (SBP)

Change From Baseline in Diastolic Blood Pressure (DBP)

Change From Baseline in Pulse Rate

Change From Baseline in Weight

Change From Baseline in BMI

Change From Baseline in SBP

Change From Baseline in DBP

Change From Baseline in Pulse Rate

Change From Baseline in Weight

Change From Baseline in BMI

Secondary Outcome Measures

Full Information

NCT ID

NCT01585558

First Posted

April 18, 2012

Last Updated

April 19, 2018

Sponsor

Shionogi

Collaborators

QuatRx Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01585558

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

May 16, 2006 (Actual)

Primary Completion Date

August 19, 2008 (Actual)

Study Completion Date

September 18, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shionogi

Collaborators

QuatRx Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group 1

Arm Type

Experimental

Arm Title

Treatment Group 2

Arm Type

Experimental

Arm Title

Treatment Group 3

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ospemifene (Dose 1)

Intervention Type

Drug

Intervention Name(s)

Ospemifene (Dose 2)

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Incidence of Adverse Events (AEs)

Time Frame

Week 20 (Phone Contact) to Week 56 (Visit 7)

Title

Assessment of Cervical Pap Smear Samples

Description

Time Frame

Week 52 (Visit 6)

Title

Assessment of Endometrial Biopsy

Description

Assessments were based on Blaustein's classification.

Time Frame

Week 52 (Visit 6)

Title

Mean Percent Change From Baseline in Serum Lipids

Time Frame

Baseline to Week 26 (Visit 5)

Title

Mean Percent Change From Baseline in Serum Lipids

Time Frame

Baseline to Week 52 (Visit 6)

Title

Mean Change in Blood Chemistry Parameters

Time Frame

Baseline to Week 26 (Visit 5)

Title

Mean Change in Blood Chemistry Parameters

Time Frame

Baseline to Week 52 (Visit 6)

Title

Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)

Description

Mean change in endometrial thickness from baseline

Time Frame

Baseline to Week 26 (Visit 5)

Title

Assessment of Endometrial Safety With a TVU

Description

Mean change in endometrial thickness from baseline

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Visual Evaluation of the Vagina

Description

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).

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Visual Evaluation of the Vagina

Description

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).

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Estradiol (E2) Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Luteinizing Hormone (LH) Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Follicle Stimulating Hormone (FSH) Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

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

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Testosterone (Total) Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Testosterone (Free) Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in E2 Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in LH Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in FSH Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in SHBG Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Assessment of Mammography

Description

Mammography was done for the detection of characteristic masses and microcalcifications in the breast.

Time Frame

Week 52 (Visit 6)

Title

Change From Baseline in Testosterone (Total) Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Testosterone (Free) Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Antithrombin Antigen, P Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Fibrinogen Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Protein C Ag, P Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Protein S Ag (Free), P Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Thromboplastin Time

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Antithrombin Antigen, P Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Fibrinogen Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Protein C Ag, P Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Protein S Ag (Free), P Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Thromboplastin Time

Time Frame

Baseline to Week 52 (Visit 6)

Title

Assessment of Breast Palpation

Description

Breast palpation was done by the investigator to assess abnormalities in the breast.

Time Frame

Week 26 (Visit 5)

Title

Assessment of Breast Palpation

Description

Breast palpation was done by the investigator to assess abnormalities in the breast.

Time Frame

Week 52 (Visit 6)

Title

Assessment of Hematology Tests

Description

Change from baseline

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Erythrocyte (RBC) Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Hemogobin Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Hematocrit Levels

Time Frame

Baseline to Week 26 (Visit 5)

Title

Assessment of Hematology Test Values

Description

Change from baseline

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Erythrocyte (RBC) Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Hemoglobin Levels

Time Frame

Baseine to Week 52 (Visit 6)

Title

Change From Baseline in Hematocrit Levels

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in pH of Urine

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Specific Gravtiy of Urine

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in pH of Urine

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Specific Gravity of Urine

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Systolic Blood Pressure (SBP)

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Diastolic Blood Pressure (DBP)

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Pulse Rate

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in Weight

Time Frame

Baseline to Week 26 (Visit 5)

Title

Change From Baseline in BMI

Time Frame

Baseline to Week 26

Title

Change From Baseline in SBP

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in DBP

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Pulse Rate

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in Weight

Time Frame

Baseline to Week 52 (Visit 6)

Title

Change From Baseline in BMI

Time Frame

Baseline to Week 52 (Visit 6)

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shionogi Clinical Trials Administrator Clinical Support Help Line

Organizational Affiliation

Shionogi

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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