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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

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ClinicalTrials.gov Identifier: NCT01585558
Recruitment Status : Completed
First Posted : April 26, 2012
Results First Posted : June 28, 2013
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
QuatRx Pharmaceuticals
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

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.

Condition or disease Intervention/treatment Phase
Atrophy Vaginal Diseases Drug: Ospemifene (Dose 1) Drug: Ospemifene (Dose 2) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 16, 2006
Actual Primary Completion Date : August 19, 2008
Actual Study Completion Date : September 18, 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ospemifene
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment Group 1 Drug: Ospemifene (Dose 1)
Experimental: Treatment Group 2 Drug: Ospemifene (Dose 2)
Placebo Comparator: Treatment Group 3 Drug: Placebo



Primary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585558


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

Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT01585558     History of Changes
Other Study ID Numbers: 15-50310X
First Posted: April 26, 2012    Key Record Dates
Results First Posted: June 28, 2013
Last Update Posted: May 21, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Vaginal Diseases
Pathological Conditions, Anatomical
Genital Diseases, Female
Atrophy
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents