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OpenTrials
Completed

NCT Number: NCT01585558

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

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.

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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
  • 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

Treatment and study plan

Ospemifene (Dose 1)

Drug

Ospemifene (Dose 2)

Drug

Placebo

Drug

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Week 20 (Phone Contact) to Week 56 (Visit 7)

  2. Assessment of Cervical Pap Smear Samples

    Time frame: Week 52 (Visit 6)

    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.

  3. Assessment of Endometrial Biopsy

    Time frame: Week 52 (Visit 6)

    Assessments were based on Blaustein's classification.

  4. Mean Percent Change From Baseline in Serum Lipids

    Time frame: Baseline to Week 26 (Visit 5)

  5. Mean Percent Change From Baseline in Serum Lipids

    Time frame: Baseline to Week 52 (Visit 6)

  6. Mean Change in Blood Chemistry Parameters

    Time frame: Baseline to Week 26 (Visit 5)

  7. Mean Change in Blood Chemistry Parameters

    Time frame: Baseline to Week 52 (Visit 6)

  8. Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)

    Time frame: Baseline to Week 26 (Visit 5)

    Mean change in endometrial thickness from baseline

  9. Assessment of Endometrial Safety With a TVU

    Time frame: Baseline to Week 52 (Visit 6)

    Mean change in endometrial thickness from baseline

  10. Change From Baseline in Visual Evaluation of the Vagina

    Time frame: Baseline to Week 26 (Visit 5)

    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).

  11. Change From Baseline in Visual Evaluation of the Vagina

    Time frame: Baseline to Week 52 (Visit 6)

    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).

  12. Change From Baseline in Estradiol (E2) Levels

    Time frame: Baseline to Week 26 (Visit 5)

  13. Change From Baseline in Luteinizing Hormone (LH) Levels

    Time frame: Baseline to Week 26 (Visit 5)

  14. Change From Baseline in Follicle Stimulating Hormone (FSH) Levels

    Time frame: Baseline to Week 26 (Visit 5)

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

    Time frame: Baseline to Week 26 (Visit 5)

  16. Change From Baseline in Testosterone (Total) Levels

    Time frame: Baseline to Week 26 (Visit 5)

  17. Change From Baseline in Testosterone (Free) Levels

    Time frame: Baseline to Week 26 (Visit 5)

  18. Change From Baseline in E2 Levels

    Time frame: Baseline to Week 52 (Visit 6)

  19. Change From Baseline in LH Levels

    Time frame: Baseline to Week 52 (Visit 6)

  20. Change From Baseline in FSH Levels

    Time frame: Baseline to Week 52 (Visit 6)

  21. Change From Baseline in SHBG Levels

    Time frame: Baseline to Week 52 (Visit 6)

  22. Assessment of Mammography

    Time frame: Week 52 (Visit 6)

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

  23. Change From Baseline in Testosterone (Total) Levels

    Time frame: Baseline to Week 52 (Visit 6)

  24. Change From Baseline in Testosterone (Free) Levels

    Time frame: Baseline to Week 52 (Visit 6)

  25. Change From Baseline in Antithrombin Antigen, P Levels

    Time frame: Baseline to Week 26 (Visit 5)

  26. Change From Baseline in Fibrinogen Levels

    Time frame: Baseline to Week 26 (Visit 5)

  27. Change From Baseline in Protein C Ag, P Levels

    Time frame: Baseline to Week 26 (Visit 5)

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

    Time frame: Baseline to Week 26 (Visit 5)

  29. Change From Baseline in Thromboplastin Time

    Time frame: Baseline to Week 26 (Visit 5)

  30. Change From Baseline in Antithrombin Antigen, P Levels

    Time frame: Baseline to Week 52 (Visit 6)

  31. Change From Baseline in Fibrinogen Levels

    Time frame: Baseline to Week 52 (Visit 6)

  32. Change From Baseline in Protein C Ag, P Levels

    Time frame: Baseline to Week 52 (Visit 6)

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

    Time frame: Baseline to Week 52 (Visit 6)

  34. Change From Baseline in Thromboplastin Time

    Time frame: Baseline to Week 52 (Visit 6)

  35. Assessment of Breast Palpation

    Time frame: Week 26 (Visit 5)

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

  36. Assessment of Breast Palpation

    Time frame: Week 52 (Visit 6)

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

  37. Assessment of Hematology Tests

    Time frame: Baseline to Week 26 (Visit 5)

    Change from baseline

  38. Change From Baseline in Erythrocyte (RBC) Levels

    Time frame: Baseline to Week 26 (Visit 5)

  39. Change From Baseline in Hemogobin Levels

    Time frame: Baseline to Week 26 (Visit 5)

  40. Change From Baseline in Hematocrit Levels

    Time frame: Baseline to Week 26 (Visit 5)

  41. Assessment of Hematology Test Values

    Time frame: Baseline to Week 52 (Visit 6)

    Change from baseline

  42. Change From Baseline in Erythrocyte (RBC) Levels

    Time frame: Baseline to Week 52 (Visit 6)

  43. Change From Baseline in Hemoglobin Levels

    Time frame: Baseine to Week 52 (Visit 6)

  44. Change From Baseline in Hematocrit Levels

    Time frame: Baseline to Week 52 (Visit 6)

  45. Change From Baseline in pH of Urine

    Time frame: Baseline to Week 26 (Visit 5)

  46. Change From Baseline in Specific Gravtiy of Urine

    Time frame: Baseline to Week 26 (Visit 5)

  47. Change From Baseline in pH of Urine

    Time frame: Baseline to Week 52 (Visit 6)

  48. Change From Baseline in Specific Gravity of Urine

    Time frame: Baseline to Week 52 (Visit 6)

  49. Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline to Week 26 (Visit 5)

  50. Change From Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline to Week 26 (Visit 5)

  51. Change From Baseline in Pulse Rate

    Time frame: Baseline to Week 26 (Visit 5)

  52. Change From Baseline in Weight

    Time frame: Baseline to Week 26 (Visit 5)

  53. Change From Baseline in BMI

    Time frame: Baseline to Week 26

  54. Change From Baseline in SBP

    Time frame: Baseline to Week 52 (Visit 6)

  55. Change From Baseline in DBP

    Time frame: Baseline to Week 52 (Visit 6)

  56. Change From Baseline in Pulse Rate

    Time frame: Baseline to Week 52 (Visit 6)

  57. Change From Baseline in Weight

    Time frame: Baseline to Week 52 (Visit 6)

  58. Change From Baseline in BMI

    Time frame: Baseline to Week 52 (Visit 6)

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Collaborators

  • QuatRx Pharmaceuticals

Registry information

Official study 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.

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.

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