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OpenTrials
Completed

NCT Number: NCT01816139

Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women

The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as measured by self-assessment, vaginal pH and vaginal smear.

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Key information

Conditions

Vulvovaginal Atrophy

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Warner Chilcott Investigational Study Site, 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

  • Signed informed consent
  • Moderate to severe vaginal dryness
  • Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with serum Follicle-stimulating hormone (FSH) > 40 milli-International Unit (mIU)/mL, 6 weeks postsurgical bilateral oophorectomy confirmed by surgical report, ultrasound or serum FSH > 40 mIU/mL, 6 weeks postsurgical hysterectomy with ovary failure confirmed by serum FSH > 40 mIU/mL
  • Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
  • Vaginal pH >5.0
  • Less than or equal 5% superficial cells on vaginal wall cytologic smear
  • Normal breast exam; if > 40 years, documentation of negative mammogram

Exclusion criteria

  • Randomization in PR-04409, participation in clinical trial or use of investigational drug within 30 days prior to screening
  • Smokes ≥ 15 cigarettes/day
  • Known or suspected premalignant or malignant disease
  • Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure, stroke or ischemic attack, thrombophlebitis or thromboembolic disorder
  • Increased frequency/severity headaches with estrogen therapy
  • Drug addiction/alcohol abuse within last 2 years
  • Currently taking St. John's Wort or anticoagulant
  • Uncontrolled hypertension or thyroid disorder, clinically significant depression or untreated urinary tract infection

Treatment and study plan

Vehicle

Drug

Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks

WC3011 Estradiol Vaginal Cream

Drug

WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks

Primary outcomes

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

    Time frame: Baseline (Day 0) to final assessment (Up to Week 12)

    Participant's self-assessment of Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.

  2. Change From Baseline in Vaginal pH to Final Assessment

    Time frame: Baseline (Day 0) to final assessment (Up to Week 12)

    Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 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. Final assessment is defined as the last available postbaseline assessment.

  3. Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment

    Time frame: Baseline (Day 0) to final assessment (Up 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. A positive change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.

  4. Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment

    Time frame: Baseline (Day 0) to final assessment (Up 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. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.

Secondary outcomes

  1. 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 Vaginal Dryness was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement.

  2. Change From Baseline in Participants Self-Assessment of the Symptoms of VVA

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

    Self-Assessment of the symptoms of VVA (vaginal and/or vulvar irritation/ Itching, dysuria, and dyspareunia) were evaluated by a questionnaire. Each symptom was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate, or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.

  3. Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity

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

    Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Number of participants with assessment "present" are reported. Final assessment is defined as the last available postbaseline assessment.

  4. Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment

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

    Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae each graded on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores are worse. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.

  5. Change From Baseline in the 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. A positive change from Baseline indicates improvement.

  6. Change From Baseline in the 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. A negative change from Baseline indicates improvement.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2013
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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