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

Sponsor:

Information provided by (Responsible Party):

Warner Chilcott

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Postmenopausal Vulvovaginal Atrophy	Drug: WC3011 Vaginal Gel Drug: Vehicle	Phase 3

Study Design


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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	35 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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 ≥ 95 mmHg

Contacts and Locations

Information from the National Library of Medicine

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

Show 72 Study Locations

Sponsors and Collaborators

Warner Chilcott

Investigators


Study Director:	Herman Ellman, MD	Warner Chilcott

More Information


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

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