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
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

  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 October 23, 2014