Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

Phase 3

Completed

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

• Registration Number: NCT01400776
• Lead Sponsor: Warner Chilcott

Brief Summary

Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-29
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-22
• Primary Completion: 2012-02-27
• Study Completion: 2012-02-27
• Disposition First Submitted: 2013-02-28
• Disposition First Submitted QC: 2013-02-28
• Disposition First Posted: 2013-03-08
• 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: 722

Inclusion Criteria

• Postmenopausal females ≥35 years with either or both ovaries removed or naturally menopausal with moderate to severe vaginal dryness

Exclusion Criteria

• Hypersensitivity to estrogen and/or progestin therapy
• Known or suspected premalignant or malignant disease (except successfully treated skin cancers)
• Manifestation of or treatment for significant cardiovascular disease, congestive heart failure, stroke or ischemic attacks
• Insulin-dependent diabetes mellitus
• Increased frequency or severity of headaches while on hormone or estrogen therapy
• Drug or alcohol addiction within last 2 years
• Participation in a clinical trial within 30 days
• Smoking ≥ 15 cigarettes daily
• Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 95 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
Vehicle (2 Times/Week)	Vehicle	Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
WC3011 Estradiol Vaginal Cream (3 Times/Week)	WC3011 Estradiol Vaginal Cream	WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
Vehicle (3 Times/Week)	Vehicle	Vehicle applied daily for 2 weeks, followed by dosing 3 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 Week 12/Final Visit	Baseline (Day 0) to Week 12/Final Visit	The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Vaginal pH to Week 12/Final Visit	Baseline (Day 0) to Week 12/Final Visit	Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit	Baseline (Day 0) to Week 12/Final Visit	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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit	Baseline (Day 0) to Week 12/Final Visit	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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit	Baseline (Day 0) to Week 12 and Week 12/Final visit	Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to atrophy scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit	Baseline (Day 0) to Week 12 and Week 12/Final visit	Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to pallor scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit	Baseline (Day 0) to Week 12 and Week 12/Final visit	Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to vaginal dryness scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit	Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit	Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Percentage of participants with assessment "present" are reported. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit	Baseline (Day 0) to Week 12 and Week 12/Final visit	Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to friability scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit	Baseline (Day 0) to Week 12 and Week 12/Final visit	Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to petechiae scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
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 symptoms of VVA (severity of vaginal dryness) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement.
Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit	Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit	Participant's self-assessment of symptoms of VVA (dyspareunia) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit	Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit	Participant's self-assessment of symptoms of VVA (vaginal and/or vulvar irritation/itching) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in Vaginal pH to Week 12	Baseline (Day 0) to Week 12	Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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.
Change From Baseline in 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.
Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit	Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit	Participant's self-assessment of symptoms of VVA (dysuria) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
Change From Baseline in 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.

Trial Locations

Locations (67)

Medical Affiliated Research Center, Inc.; 🇺🇸 Huntsville, Alabama, United States

Mobile OB-GYN, PC; 🇺🇸 Mobile, Alabama, United States

Women's Health Research; 🇺🇸 Phoenix, Arizona, United States

Precision Trials, LLC; 🇺🇸 Phoenix, Arizona, United States

Radiant Research-Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Radiant Research-Tucson; 🇺🇸 Tucson, Arizona, United States

Visions Clinical Research-tucson; 🇺🇸 Tucson, Arizona, United States

Genesis Center for Clinical Research; 🇺🇸 San Diego, California, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Women's Healthcare Inc.; 🇺🇸 San Diego, California, United States

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