Trial record 12 of 464 for:    Vaginal Diseases: Clinical Trials

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

This study has been completed.
Sponsor:
Collaborator:
QuatRx Pharmaceuticals
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT01585558
First received: April 18, 2012
Last updated: May 21, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Atrophy
Vaginal Diseases
Drug: Ospemifene (Dose 1)
Drug: Ospemifene (Dose 2)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • Incidence of Adverse Events (AEs) [ Time Frame: Week 20 (Phone Contact) to Week 56 (Visit 7) ] [ Designated as safety issue: Yes ]
  • Assessment of Cervical Pap Smear Samples [ Time Frame: Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
    Assessments were based on Blaustein's classification.

  • Mean Percent Change From Baseline in Serum Lipids [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Mean Percent Change From Baseline in Serum Lipids [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Mean Change in Blood Chemistry Parameters [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Mean Change in Blood Chemistry Parameters [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU) [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
    Mean change in endometrial thickness from baseline

  • Assessment of Endometrial Safety With a TVU [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
    Mean change in endometrial thickness from baseline

  • Change From Baseline in Visual Evaluation of the Vagina [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Luteinizing Hormone (LH) Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Follicle Stimulating Hormone (FSH) Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Testosterone (Total) Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Testosterone (Free) Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in E2 Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in LH Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in FSH Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in SHBG Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Assessment of Mammography [ Time Frame: Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
    Mammography was done for the detection of characteristic masses and microcalcifications in the breast.

  • Change From Baseline in Testosterone (Total) Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Testosterone (Free) Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Antithrombin Antigen, P Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Fibrinogen Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Protein C Ag, P Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Protein S Ag (Free), P Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Thromboplastin Time [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Antithrombin Antigen, P Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Fibrinogen Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Protein C Ag, P Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Protein S Ag (Free), P Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Thromboplastin Time [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Assessment of Breast Palpation [ Time Frame: Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
    Breast palpation was done by the investigator to assess abnormalities in the breast.

  • Assessment of Breast Palpation [ Time Frame: Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
    Breast palpation was done by the investigator to assess abnormalities in the breast.

  • Assessment of Hematology Tests [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Change From Baseline in Erythrocyte (RBC) Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Hemogobin Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Hematocrit Levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Assessment of Hematology Tests [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Change From Baseline in Erythrocyte (RBC) Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Hemoglobin Levels [ Time Frame: Baseine to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Hematocrit Levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in pH of Urine [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Specific Gravtiy of Urine [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in pH of Urine [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Specific Gravity of Urine [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Pulse Rate [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Weight [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in BMI [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in SBP [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in DBP [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Pulse Rate [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Weight [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in BMI [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: May 2006
Study Completion Date: September 2008
Arms Assigned Interventions
Experimental: Treatment Group 1 Drug: Ospemifene (Dose 1)
Experimental: Treatment Group 2 Drug: Ospemifene (Dose 2)
Placebo Comparator: Treatment Group 3 Drug: Placebo

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585558

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: NCT01585558     History of Changes
Other Study ID Numbers: 15-50310X
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
Urogenital atrophy
Vulvar and vaginal atrophy in menopausal women
Vaginal atrophy

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

ClinicalTrials.gov processed this record on April 23, 2014