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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

576

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach

1 country

48 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

January 31, 2013

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed

8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2013

Completed

8.5 years until next milestone

Results Posted

Study results publicly available

May 9, 2022

Completed

Last Updated

May 9, 2022

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

March 13, 2013

Results QC Date

April 11, 2022

Last Update Submit

April 11, 2022

Conditions

Vulvovaginal Atrophy

Keywords

vaginal drynessvaginal atrophyestrogen

Outcome Measures

Primary Outcomes (4)

Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment
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.
Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Final Assessment
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.
Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment
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.
Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment
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.
Baseline (Day 0) to final assessment (Up to Week 12)

Secondary Outcomes (6)

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
Change From Baseline in Participants Self-Assessment of the Symptoms of VVA
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Final Assessment
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity
Baseline (Day 0) and Weeks 2, 4, 8, 12 and Final Assessment
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
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
Baseline (Day 0) to Week 12
+1 more secondary outcomes

Study Arms (2)

Vehicle (2 Times/Week)

EXPERIMENTAL

Vehicle applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

Drug: Vehicle

WC3011 Estradiol Vaginal Cream (2 Times/Week)

PLACEBO COMPARATOR

WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks.

Drug: WC3011 Estradiol Vaginal Cream

Interventions

VehicleDRUG

Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks

Vehicle (2 Times/Week)

WC3011 Estradiol Vaginal CreamDRUG

WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks

WC3011 Estradiol Vaginal Cream (2 Times/Week)

Eligibility Criteria

Age35 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.