Clinical trial NCT02638337: Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginal Dryness
Keywords: Vulvo-vaginal Atrophy
menopause
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-23
Enrollment: 631
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 objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.


Eligibility criteria: Inclusion Criteria:

* Subject is postmenopausal.
* Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

Exclusion Criteria:

* Subject has clinically significant abnormal findings in the physical examination.
* Subject has a body mass index (BMI) equal to or greater than 38 kg/m\^2
* Subject has uncontrolled hypertension.
* Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy.
* Subject has uterine/vaginal bleeding of unknown origin.
* Subject has a vaginal infection requiring medication (may be treated and be eligible for study).

Primary outcomes:
measure: Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in the Vaginal pH at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of study drug up to 14 days after the last dose; 14 weeks
Secondary outcomes:
measure: Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Weeks 4 and 8
timeFrame: Baseline and Weeks 4 and 8
measure: Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Weeks 4 and 8
timeFrame: Baseline and Weeks 4 and 8
measure: Change From Baseline in the Vaginal pH
timeFrame: Baseline and Weeks 4 and 8
measure: Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Weeks 4 and 8
timeFrame: Baseline and Weeks 4 and 8
measure: Change From Baseline in Vaginal and/or Vulvar Irritation or Itching
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Difficult or Painful Urination
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Vaginal Pain Associated With Sexual Activity
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Vaginal Bleeding Associated With Sexual Activity
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Maturation Value
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Percentage of Participants Who Were Responders at Week 4, Week 8, and Week 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Vaginal Health Index
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Vulvar Health Index
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Vulvovaginal Imaging Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Female Sexual Function Index Total Score
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Female Sexual Function Index Domain Scores at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Urinary Distress Inventory (UDI)-6 Total Score
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Bone Sialoprotein at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Type I Collagen C-Telopeptide (CTX) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Deoxypyridinoline at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Type I Collagen N-Telopeptide (NTX) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Tartrate-Resistant Acid Phosphatase 5b at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Alkaline Phosphatase at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Bone-specific Alkaline Phosphatase at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Osteocalcin at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Procollagen 1 N-Terminal Propeptide (P1NP) at Week 12
timeFrame: Baseline and Week 12
measure: Mean Days of Lubricant Use Per Week
timeFrame: Week 1 to Week 12
measure: Mean Days of Intercourse Per Week
timeFrame: Week 1 to Week 12
measure: Overall Satisfaction With Treatment at Week 12
timeFrame: Week 12
measure: Change From Baseline in Estradiol at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Follicle-Stimulating Hormone at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Luteinizing Hormone at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Sex Hormone-Binding Globulin at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Testosterone at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Free Testosterone at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References:
citation: Archer DF, Goldstein SR, Simon JA, Waldbaum AS, Sussman SA, Altomare C, Zhu J, Yoshida Y, Schaffer S, Soulban G. Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial. Menopause. 2019 Jan 28;26(6):611-621. doi: 10.1097/GME.0000000000001292.