Brief Summary

The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.

Trial Health

On Track

Trial Health Score

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

Enrollment

550

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Apr 2013

Shorter than P25 for phase_3

Geographic Reach

1 country

57 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

7 months study duration

Study Start

First participant enrolled

April 12, 2013

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2013

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 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

7 months

First QC Date

April 25, 2013

Results QC Date

April 11, 2022

Last Update Submit

April 11, 2022

Conditions

Vulvovaginal Atrophy

Keywords

Vulvovaginal AtrophyDyspareuniaPostmenopausal

Outcome Measures

Primary Outcomes (4)

Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment
Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates 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.
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 post-baseline assessment for the given efficacy endpoint.
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 (7)

Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
Baseline to Weeks 2, 4, 8 and 12
Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment
Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit
Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
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 (Up to Week 12)
Change From Baseline in Vaginal pH to Week 12
Baseline to Week 12
+2 more secondary outcomes

Study Arms (2)

Vehicle (3 Times/Week)

ACTIVE COMPARATOR

Vehicle applied to the vagina daily for 14 days followed by dosing 3 times per week for 10 weeks.

Drug: Vehicle

WC3011 Estradiol Vaginal Cream (3 Times/Week)

EXPERIMENTAL

WC3011 Estradiol vaginal cream applied daily for 14 days followed by dosing 3 times per week for 10 weeks.

Drug: WC3011 Estradiol Vaginal Cream

Interventions

WC3011 Estradiol Vaginal CreamDRUG

Daily for 14 days followed by 3 times per week for 10 weeks

Also known as: WC3011

WC3011 Estradiol Vaginal Cream (3 Times/Week)

VehicleDRUG

Daily for 14 days followed by 3 times per week for 10 weeks

Vehicle (3 Times/Week)

Eligibility Criteria

Age35 Years+

Sexfemale

Healthy VolunteersNo

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

You may qualify if:

Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)
Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) \>40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH \>40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH \>40 mIU/mL
Age ≥40 years; ≥35 with bilateral oophorectomy
Vaginal pH \>5.0
Less than or equal to 5% superficial cells on vaginal wall cytologic smear
Normal clinical breast exam or negative mammogram if ≥ 40 years of age
Negative urine pregnancy test (non-hysterectomized and \<12 months amenorrhea)

You may not qualify if:

Enrollment in Sponsor's Study PR-04409 or PR-05812
Participation in clinical trial or use of investigational drug within 30 days prior to screening
Known hypersensitivity to estrogen and/or progestin therapy
Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or \>50% angiographic narrowing of coronary artery
Thrombophlebitis or thromboembolic disorder or history of
Insulin-dependent diabetes mellitus
Increased frequency or severity of headaches while on hormone or estrogen therapy
Currently taking St. John's Wort
Drug/alcohol addiction within past 2 years
Treatment with anticoagulants (heparin or warfarin)
Smoking ≥15 cigarettes/day

Contact the study team to confirm eligibility.