Safety & Efficacy WC3011 in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women - Full Text View

Purpose

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

Condition	Intervention	Phase
Postmenopausal Vulvovaginal Atrophy	Drug: WC3011 Vaginal Gel Drug: Vehicle	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Further study details as provided by Warner Chilcott:

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 ] [ Designated as safety issue: No ]
Change in Vaginal pH from Baseline to Week 12/Final Visit [ Time Frame: Baseline and Week 12/Final Visit ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Investigator Assessment of Vulvovaginal Atrophy (VVA) from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Intensity of Vaginal Dryness from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Intensity of Vaginal Dryness from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Vaginal and/or Vulvar Irritation/Itching from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Vaginal and/or Vulvar Irritation/Itching from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Vaginal and/or Vulvar Irritation/Itching from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Dysuria (painful or difficult urination) from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Dysuria (painful or difficult urination) from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Dysuria (painful or difficult urination) from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Dyspareunia (pain associated with sexual activity) from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Dyspareunia (pain associated with sexual activity) from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Dyspareunia (pain associated with sexual activity) from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Vaginal Bleeding associated with sexual activity from Baseline to Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Vaginal Bleeding associated with sexual activity from Baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Change in Subjects' Self-Assessment of Vaginal Bleeding associated with sexual activity from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]


Enrollment:	722
Study Start Date:	July 2011
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	35 Years and older
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400776

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Sponsors and Collaborators

Warner Chilcott

Investigators


Study Director:	Herman Ellman, MD	Warner Chilcott

More Information

No publications provided


Responsible Party:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT01400776 History of Changes
Other Study ID Numbers:	PR-04409.3
Study First Received:	July 20, 2011
Last Updated:	March 11, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Warner Chilcott:


Postmenopausal Women, Vaginal Dryness

Additional relevant MeSH terms:


Atrophy Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on March 03, 2015

Safety & Efficacy WC3011 in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women (VENUS)