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Completed

NCT Number: NCT02670785

A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.

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Key information

Conditions

Vulvovaginal Atrophy Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Menopause Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Visions Clinical Research-Tucson, Tucson, Arizona, 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

  • Clinical diagnosis of vulvovaginal atrophy due to post menopause
  • Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
  • Moderate to severe vaginal dryness
  • Normal breast exam; if > 40 years
  • Vaginal pH > 5.0
  • < 5% superficial cells on vaginal wall cytology smear

Exclusion criteria

  • Known hypersensitivity to estrogen and/or progestin therapy
  • Known or suspected premalignant or malignant disease
  • Undiagnosed abnormal genital bleeding
  • A history of or treatment for significant cardiovascular disease, congestive heart failure, or stroke
  • Active or known protein C, protein S, or antithrombin deficient, or other known thrombophilic disorders or thromboembolic events
  • Increased frequency/severity headaches with estrogen therapy
  • Smokes ≥ 15 cigarettes/day

Treatment and study plan

Estradiol Vaginal Capsule (EVC)

Drug

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Placebo

Drug

Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks

Primary outcomes

  1. Change in the percentage of vaginal superficial cells

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

  2. Change in the percentage of vaginal parabasal cells

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

  3. Change in vaginal pH

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

Secondary outcomes

  1. Change in the investigator assessment of VVA measured by scoring the vaginal health in 5 categories using a 4-point scale

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  2. Change in subject's self-assessment of vaginal dryness reported as the most bothersome symptom

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  3. Change in subject's self-assessment of dyspareunia reported as the most bothersome symptom

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  4. Change in subject's self-assessment of dysuria

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  5. Change in subject's self-assessment of vaginal and/or vulvar irritation/itching

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  6. Change in subject's self-assessment of vaginal dryness in patients where vaginal dryness was not reported as the most bothersome symptom

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  7. Change in subject's self-assessment of dyspareunia in patients where dyspareunia was not reported as the most bothersome symptom

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

    Outcome was measured by using a 4-point severity scale with: None=0, Mild=1, Moderate=2, and Severe=3.

  8. Self-assessment by sexually active participants as to the presence or absence of vaginal bleeding

    Time frame: Baseline (Week 0) to Final Visit (Week 6)

    Total number of participants who were sexually active assessed if vaginal bleeding was present or absent.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate Safety and Efficacy of Three Doses of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2016
Registry last updated
Aug 23, 2017

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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