Phase 3 N=722 Randomized Triple-blind Treatment

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

Postmenopausal Vulvovaginal Atrophy

Bottom Line

View on ClinicalTrials.gov: NCT01400776 ↗

Enrolled (actual)

722

Serious AEs

0.3%

Results posted

May 2022

Primary outcome: Primary: Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit — 2.49; 2.46; 2.50; 2.50 score on a scale

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit	2.49; 2.46; 2.50; 2.50; -1.27; -0.99	—
PRIMARY Change From Baseline in Vaginal pH to Week 12/Final Visit	6.51; 6.49; 6.40; 6.40; -1.08; -0.37	—
PRIMARY Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit	0.85; 0.66; 0.79; 0.66; 11.44; 3.05	—
PRIMARY Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit	48.36; 47.78; 42.56; 45.24; 41.7; -8.20	—
SECONDARY Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit	1.88; 1.94; 1.90; 1.88; -0.77; -0.47	—
SECONDARY Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit	1.76; 1.72; 1.74; 1.83; -0.73; -0.36	—
SECONDARY Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit	1.92; 1.85; 1.83; 1.87; -0.94; -0.53	—
SECONDARY Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit	1.04; 1.02; 0.94; 1.04; -0.66; -0.47	—
SECONDARY Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit	0.74; 0.89; 0.70; 0.71; -0.47; -0.38	—
SECONDARY Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12	2.49; 2.46; 2.50; 2.50; -0.83; -0.79	—
SECONDARY 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	1.26; 1.33; 1.11; 1.20; -0.54; -0.67	—
SECONDARY 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	0.38; 0.49; 0.45; 0.53; -0.24; -0.22	—
SECONDARY 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	2.29; 2.23; 2.29; 2.38; -0.79; -0.78	—
SECONDARY 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	15.81; 17.89; 17.75; 24.79; 6.55; 7.32	—
SECONDARY Change From Baseline in Vaginal pH to Week 12	6.51; 6.49; 6.40; 6.40; -1.10; -0.34	—
SECONDARY Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12	0.85; 0.66; 0.79; 0.66; 11.66; 3.17	—
SECONDARY Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12	48.36; 47.78; 42.56; 45.24; -42.3; -8.08	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01400776). 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.