Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women

Phase 3

Completed

• Conditions: Vulvovaginal Atrophy
• Interventions: Drug: Vehicle; Drug: WC3011 Estradiol Vaginal Cream

• Registration Number: NCT01816139
• Lead Sponsor: Warner Chilcott

Brief Summary

The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-31
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-21
• Primary Completion: 2013-11-19
• Study Completion: 2013-11-19
• Disposition First Submitted: 2015-02-24
• Disposition First Submitted QC: 2015-02-24
• Disposition First Posted: 2015-03-17
• Status Verified: 2021-09
• Results First Submitted: 2022-04-11
• Results First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Results First Posted: 2022-05-09
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 576

Inclusion Criteria

• Signed informed consent
• Moderate to severe vaginal dryness
• Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with serum Follicle-stimulating hormone (FSH) > 40 milli-International Unit (mIU)/mL, 6 weeks postsurgical bilateral oophorectomy confirmed by surgical report, ultrasound or serum FSH > 40 mIU/mL, 6 weeks postsurgical hysterectomy with ovary failure confirmed by serum FSH > 40 mIU/mL
• Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
• Vaginal pH >5.0
• Less than or equal 5% superficial cells on vaginal wall cytologic smear
• Normal breast exam; if > 40 years, documentation of negative mammogram

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Exclusion Criteria

• Randomization in PR-04409, participation in clinical trial or use of investigational drug within 30 days prior to screening
• Smokes ≥ 15 cigarettes/day
• Known or suspected premalignant or malignant disease
• Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure, stroke or ischemic attack, thrombophlebitis or thromboembolic disorder
• Increased frequency/severity headaches with estrogen therapy
• Drug addiction/alcohol abuse within last 2 years
• Currently taking St. John's Wort or anticoagulant
• Uncontrolled hypertension or thyroid disorder, clinically significant depression or untreated urinary tract infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle (2 Times/Week)	Vehicle	Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.
WC3011 Estradiol Vaginal Cream (2 Times/Week)	WC3011 Estradiol Vaginal Cream	WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment	Baseline (Day 0) to final assessment (Up to Week 12)	Participant's self-assessment of Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment	Baseline (Day 0) to final assessment (Up to Week 12)	Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Change From Baseline in Vaginal pH to Final Assessment	Baseline (Day 0) to final assessment (Up to Week 12)	Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment	Baseline (Day 0) to final assessment (Up to Week 12)	Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment	Baseline (Day 0) to Week 12 and Final Assessment	Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae each graded on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores are worse. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12	Baseline (Day 0) to Week 12	Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement.
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8, and 12	Baseline (Day 0) to Weeks 2, 4, 8, and 12	Participant's self-assessment of Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement.
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA	Baseline (Day 0) to Weeks 2, 4, 8, 12 and Final Assessment	Self-Assessment of the symptoms of VVA (vaginal and/or vulvar irritation/ Itching, dysuria, and dyspareunia) were evaluated by a questionnaire. Each symptom was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate, or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity	Baseline (Day 0) and Weeks 2, 4, 8, 12 and Final Assessment	Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Number of participants with assessment "present" are reported. Final assessment is defined as the last available postbaseline assessment.
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12	Baseline (Day 0) to Week 12	Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement.

Trial Locations

Locations (1)

Warner Chilcott Investigational Study Site; 🇺🇸 Spokane, Washington, United States