Clinical trial 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrophy
Vaginal Diseases
Keywords: Menopausal symptoms
Urogenital atrophy
Vulvar and vaginal atrophy in menopausal women
Vaginal atrophy
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
Collaborators: name: QuatRx Pharmaceuticals
First posted: 2012-04-26
Enrollment: 180
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Week 20 (Phone Contact) to Week 56 (Visit 7)
measure: Assessment of Cervical Pap Smear Samples
timeFrame: Week 52 (Visit 6)
measure: Assessment of Endometrial Biopsy
timeFrame: Week 52 (Visit 6)
measure: Mean Percent Change From Baseline in Serum Lipids
timeFrame: Baseline to Week 26 (Visit 5)
measure: Mean Percent Change From Baseline in Serum Lipids
timeFrame: Baseline to Week 52 (Visit 6)
measure: Mean Change in Blood Chemistry Parameters
timeFrame: Baseline to Week 26 (Visit 5)
measure: Mean Change in Blood Chemistry Parameters
timeFrame: Baseline to Week 52 (Visit 6)
measure: Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)
timeFrame: Baseline to Week 26 (Visit 5)
measure: Assessment of Endometrial Safety With a TVU
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Visual Evaluation of the Vagina
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Visual Evaluation of the Vagina
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Estradiol (E2) Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Luteinizing Hormone (LH) Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Follicle Stimulating Hormone (FSH) Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Testosterone (Total) Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Testosterone (Free) Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in E2 Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in LH Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in FSH Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in SHBG Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Assessment of Mammography
timeFrame: Week 52 (Visit 6)
measure: Change From Baseline in Testosterone (Total) Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Testosterone (Free) Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Antithrombin Antigen, P Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Fibrinogen Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Protein C Ag, P Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Protein S Ag (Free), P Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Thromboplastin Time
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Antithrombin Antigen, P Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Fibrinogen Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Protein C Ag, P Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Protein S Ag (Free), P Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Thromboplastin Time
timeFrame: Baseline to Week 52 (Visit 6)
measure: Assessment of Breast Palpation
timeFrame: Week 26 (Visit 5)
measure: Assessment of Breast Palpation
timeFrame: Week 52 (Visit 6)
measure: Assessment of Hematology Tests
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Erythrocyte (RBC) Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Hemogobin Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Hematocrit Levels
timeFrame: Baseline to Week 26 (Visit 5)
measure: Assessment of Hematology Test Values
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Erythrocyte (RBC) Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Hemoglobin Levels
timeFrame: Baseine to Week 52 (Visit 6)
measure: Change From Baseline in Hematocrit Levels
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in pH of Urine
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Specific Gravtiy of Urine
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in pH of Urine
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Specific Gravity of Urine
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Pulse Rate
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in Weight
timeFrame: Baseline to Week 26 (Visit 5)
measure: Change From Baseline in BMI
timeFrame: Baseline to Week 26
measure: Change From Baseline in SBP
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in DBP
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Pulse Rate
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in Weight
timeFrame: Baseline to Week 52 (Visit 6)
measure: Change From Baseline in BMI
timeFrame: Baseline to Week 52 (Visit 6)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References: