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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01400776
First received: July 20, 2011
Last updated: March 11, 2013
Last verified: March 2013
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400776

  Show 72 Study Locations
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 April 17, 2014