Skip to main content
OpenTrials
Completed

NCT Number: NCT01586364

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrophy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases Vaginal Diseases

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ospemifene 60Mg Oral Tablet

Drug

Other names: Osphena®

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Week 13 (Phone Contact) to Week 56 (Visit 4)

  2. Change From Baseline in Serum Lipid Levels at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

  3. Change From Baseline in Serum Lipid Levels at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  4. Change From Baseline in Blood Pressure at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

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

  5. Change From Baseline in Pulse Rate at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

  6. Change From Baseline in Weight at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

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

    Time frame: Baseline to Week 26 (Visit 2)

  8. Change From Baseline in Blood Pressure at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  9. Change From Baseline in Pulse Rate at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  10. Change From Baseline in Weight at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  11. Change From Baseline in BMI at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  12. Change From Baseline in Visual Evaluation of Vagina at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

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

  13. Change From Baseline in Visual Evaluation of Vagina at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

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

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

    Time frame: Week 52 (Visit 3)

    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.

  15. Assessment of Breast Palpation at Visit 2

    Time frame: Week 26 (Visit 2)

    Breast palpation was used to assess breast abnormalities.

  16. Assessment of Breast Palpation at Visit 3

    Time frame: Week 52 (Visit 3)

    Breast palpation was used to assess breast abnormalities.

  17. 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)

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

    Time frame: Baseline to Week 26 (Visit 2)

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

    Time frame: Baseline to Week 26 (Visit 2)

  20. 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)

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

    Time frame: Baseline to Week 52 (Visit 3)

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

    Time frame: Baseline to Week 52 (Visit 3)

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

    Time frame: Baseline to Week 26 (Visit 2)

  24. Change From Baseline in Erythrocyte Levels at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

  25. Change From Baseline in Hemoglobin Levels at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

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

    Time frame: Baseline to Week 26 (Visit 2)

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

    Time frame: Baseline to Week 26 (Visit 2)

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

    Time frame: Baseline to Week 52 (Visit 3)

  29. Change From Baseline in Erythrocyte Levels at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  30. Change From Baseline in Hemoglobin Levels at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

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

    Time frame: Baseline to Week 52 (Visit 3)

  32. Change From Baseline in MCV and MPV at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

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

    Time frame: Baseline to Week 26 (Visit 2)

  34. 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)

  35. 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)

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

    Time frame: Baseline to Week 52 (Visit 3)

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

    Time frame: Baseline to Week 52 (Visit 3)

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

    Time frame: Baseline to Week 52 (Visit 3)

  39. Change From Baseline in pH of Urine at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

  40. Change From Baseline in Specific Gravity of Urine at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

  41. Change From Baseline in pH of Urine at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  42. Change From Baseline in Specific Gravity of Urine at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

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

    Time frame: Baseline to Week 26 (Visit 2)

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

    Time frame: Baseline to Week 26 (Visit 2)

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

    Time frame: Baseline to Week 26 (Visit 2)

  46. Change From Baseline in Testosterone Levels at Visit 2

    Time frame: Baseline to Week 26 (Visit 2)

  47. Change From Baseline in E2 Levels at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  48. Change From Baseline in FSH and LH Levels at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  49. Change From Baseline in SHBG Levels at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

  50. Change From Baseline in Testosterone Levels at Visit 3

    Time frame: Baseline to Week 52 (Visit 3)

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Collaborators

  • QuatRx Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 26, 2012
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.