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Completed

NCT Number: NCT01400776

Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women

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

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Key information

Conditions

Postmenopausal Vulvovaginal Atrophy

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Medical Affiliated Research Center, Inc., Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 BP ≥ 95 mmHg

Treatment and study plan

WC3011 Estradiol Vaginal Cream

Drug

WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks

Vehicle

Drug

Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.

Primary outcomes

  1. Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit

    Time frame: Baseline (Day 0) to Week 12/Final Visit

    The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  2. Change From Baseline in Vaginal pH to Week 12/Final Visit

    Time frame: Baseline (Day 0) to Week 12/Final Visit

    Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  3. Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit

    Time frame: Baseline (Day 0) to Week 12/Final Visit

    Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  4. Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit

    Time frame: Baseline (Day 0) to Week 12/Final Visit

    Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

Secondary outcomes

  1. Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit

    Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit

    Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to atrophy scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  2. Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit

    Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit

    Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to pallor scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  3. Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit

    Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit

    Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to vaginal dryness scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  4. Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit

    Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit

    Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to friability scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  5. Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit

    Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit

    Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to petechiae scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  6. Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12

    Time frame: Baseline (Day 0) to Weeks 2, 4, 8 and 12

    Participant's self-assessment of symptoms of VVA (severity of vaginal dryness) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement.

  7. Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit

    Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit

    Participant's self-assessment of symptoms of VVA (vaginal and/or vulvar irritation/itching) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  8. Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit

    Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit

    Participant's self-assessment of symptoms of VVA (dysuria) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  9. Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit

    Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit

    Participant's self-assessment of symptoms of VVA (dyspareunia) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  10. Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit

    Time frame: Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit

    Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Percentage of participants with assessment "present" are reported. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.

  11. Change From Baseline in Vaginal pH to Week 12

    Time frame: Baseline (Day 0) to Week 12

    Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement.

  12. Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12

    Time frame: Baseline (Day 0) to Week 12

    Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells.

  13. Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12

    Time frame: Baseline (Day 0) to Week 12

    Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

Acronym: VENUS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2011
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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