Safety & Efficacy WC3011 in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women (VENUS)
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ClinicalTrials.gov Identifier: NCT01400776 |
Recruitment Status
:
Completed
First Posted
: July 22, 2011
Last Update Posted
: March 17, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postmenopausal Vulvovaginal Atrophy | Drug: WC3011 Vaginal Gel Drug: Vehicle | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 722 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of WC3011 in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Vaginal Gel Three Times Weekly
Estradiol gel applied vaginally daily for 2 weeks, followed by dosing 3X/week for 10 weeks
|
Drug: WC3011 Vaginal Gel
WC3011 Vaginal Gel administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
|
Placebo Comparator: Vehicle Twice Weekly
Vehicle Vaginal Gel applied daily for 2 weeks, followed by dosing 2X/week for 10 weeks
|
Drug: Vehicle
Vehicle Vaginal Gel administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
|
Experimental: Vaginal Gel Twice Weekly
Estradiol gel applied vaginally daily for 2 weeks, followed by dosing 2X/week for 10 weeks
|
Drug: WC3011 Vaginal Gel
WC3011 Vaginal Gel administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
|
Placebo Comparator: Vehicle Three Times Weekly
Vehicle Vaginal Gel applied daily for 2 weeks, followed by dosing 3X/week for 10 weeks
|
Drug: Vehicle
Vehicle Vaginal Gel administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
|
- Change in Vaginal Cytology (Maturation Index; Percentage of Basal and Superficial Cells) from Baseline to Week 12/Final Visit [ Time Frame: Baseline and Week 12/Final Visit ]
- Change in Vaginal pH from Baseline to Week 12/Final Visit [ Time Frame: Baseline and Week 12/Final Visit ]
- Change in Subject's Self-Assessment of Intensity of Vaginal Dryness from Baseline to Week 12/Final Visit [ Time Frame: Baseline and Week 12/Final Visit ]
- Change in Investigator Assessment of Vulvovaginal Atrophy (VVA) from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
- Change in Subjects' Self-Assessment of Intensity of Vaginal Dryness from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
- Change in Subjects' Self-Assessment of Intensity of Vaginal Dryness from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ]
- Change in Subjects' Self-Assessment of Vaginal and/or Vulvar Irritation/Itching from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
- Change in Subjects' Self-Assessment of Vaginal and/or Vulvar Irritation/Itching from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ]
- Change in Subjects' Self-Assessment of Vaginal and/or Vulvar Irritation/Itching from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
- Change in Subjects' Self-Assessment of Dysuria (painful or difficult urination) from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
- Change in Subjects' Self-Assessment of Dysuria (painful or difficult urination) from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ]
- Change in Subjects' Self-Assessment of Dysuria (painful or difficult urination) from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
- Change in Subjects' Self-Assessment of Dyspareunia (pain associated with sexual activity) from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
- Change in Subjects' Self-Assessment of Dyspareunia (pain associated with sexual activity) from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ]
- Change in Subjects' Self-Assessment of Dyspareunia (pain associated with sexual activity) from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
- Change in Subjects' Self-Assessment of Vaginal Bleeding associated with sexual activity from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ]
- Change in Subjects' Self-Assessment of Vaginal Bleeding associated with sexual activity from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ]
- Change in Subjects' Self-Assessment of Vaginal Bleeding associated with sexual activity from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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Ages Eligible for Study: | 35 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 ≥ 95 mmHg

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400776

Study Director: | Herman Ellman, MD | Warner Chilcott |
Responsible Party: | Warner Chilcott |
ClinicalTrials.gov Identifier: | NCT01400776 History of Changes |
Other Study ID Numbers: |
PR-04409.3 |
First Posted: | July 22, 2011 Key Record Dates |
Last Update Posted: | March 17, 2015 |
Last Verified: | February 2015 |
Keywords provided by Warner Chilcott:
Postmenopausal Women, Vaginal Dryness |
Additional relevant MeSH terms:
Atrophy Pathological Conditions, Anatomical |