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

This study has been completed.
Sponsor:
Collaborator:
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT01586364
First received: April 18, 2012
Last updated: May 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Atrophy
Vaginal Diseases
Drug: Ospemifene
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • Incidence of Adverse Events (AEs) [ Time Frame: Week 13 (Phone Contact) to Week 56 (Visit 4) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Serum Lipid Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Serum Lipid Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Blood Pressure at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
    Systolic blood pressure (SBP), diastolic blood pressure (DBP)

  • Change From Baseline in Pulse Rate at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Weight at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Body Mass Index (BMI) at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Blood Pressure at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Pulse Rate at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Weight at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in BMI at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Visual Evaluation of Vagina at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
    Breast palpation was used to assess breast abnormalities.

  • Assessment of Breast Palpation at Visit 3 [ Time Frame: Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Erythrocyte Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Hemoglobin Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Erythrocyte Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Hemoglobin Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in MCV and MPV at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Albumin and Total Protein Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Albumin and Total Protein Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in ALT, AST and CK Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in pH of Urine at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Specific Gravity of Urine at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in pH of Urine at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Specific Gravity of Urine at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Estradiol (E2) Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Testosterone Levels at Visit 2 [ Time Frame: Baseline to Week 26 (Visit 2) ] [ Designated as safety issue: No ]
  • Change From Baseline in E2 Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in FSH and LH Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in SHBG Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Testosterone Levels at Visit 3 [ Time Frame: Baseline to Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]

Enrollment: 301
Study Start Date: May 2006
Arms Assigned Interventions
Experimental: Treatment Arm Drug: Ospemifene

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586364

Sponsors and Collaborators
Shionogi
QuatRx Pharmaceuticals
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

No publications provided

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier: NCT01586364     History of Changes
Other Study ID Numbers: 15-50312
Study First Received: April 18, 2012
Results First Received: March 20, 2013
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:
Menopausal symptoms
Vulvar and vaginal atrophy in menopausal women
Vaginal atrophy
Urogenital atrophy

Additional relevant MeSH terms:
Atrophy
Vaginal Diseases
Pathological Conditions, Anatomical
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014