Phase 3 N=309 Treatment

Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)

Vulvovaginal Atrophy

Bottom Line

View on ClinicalTrials.gov: NCT01455597 ↗

Enrolled (actual)

309

Serious AEs

2.6%

Results posted

May 2022

Primary outcome: Primary: Number of Participants With Endometrial Biopsy Results at Final Visit — 3; 10; 7; 166 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: WC3011 Estradiol Vaginal Cream (Drug)
Age: Adult, Older Adult · 35+ yrs
Sex: Female
Sponsor: Warner Chilcott
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Endometrial Biopsy Results at Final Visit	3; 10; 7; 166; 0; 1	—
SECONDARY Change From Baseline in Participants Self-Assessment of the Symptoms of Vulvovaginal Atrophy (VVA) at Each Post-baseline Timepoints	1.2; 1.5; 1.2; 1.5; -0.3; -0.3	—
SECONDARY Change From Baseline in Vaginal Cytology: Percentage of Superficial Vaginal Cells	10.4; 4.0; 16.1; 3.1; 12.8; 17.6	—
SECONDARY Change From Baseline in Vaginal Cytology: Percentage of Parabasal Vaginal Cells	9.7; 42.2; 12.0; 34.2; 0.0; -42.2	—
SECONDARY Change From Baseline in Vaginal pH	5.5; 6.2; 5.4; 6.1; -0.3; -1.0	—
SECONDARY Change From Baseline as Per Investigator's Assessment of Each of the Signs of VVA	1.1; 1.5; 1.1; 1.4; -0.3; -0.7	—
SECONDARY Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)	195	—

Summary

This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.

Eligibility Criteria

Inclusion Criteria

Completed Study PR-04409.3 (NCT01400776)

Exclusion Criteria

Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011:

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, stroke or ischemic attack
Insulin-dependent diabetes mellitus
Smoking ≥ 15 cigarettes daily
Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01455597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.