Study to Evaluate Safety & Efficacy of WC3011 in Postmenopausal Women With Dyspareunia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01845649
First received: April 25, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by subject self-assessment when compared to vehicle.


Condition Intervention Phase
Vulvovaginal Atrophy
Drug: Estradiol 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, Multicenter, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of WC3011 in Postmenopausal Women With Dyspareunia

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Change in Intensity of Dyspareunia, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change in Maturation Index [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Vaginal wall smear; Maturation Index = 0.2 x parabasal + 0.6 x intermediate + 1.0 x superficial

  • Change in Vaginal pH [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Vaginal and/or Vulvar Irritation/Itching, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change in Dysuria (painful or difficult urination), Subject Self-Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change in Vaginal Bleeding Associated with Sexual Activity, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change in Vaginal Dryness, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 550
Study Start Date: April 2013
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active
Estradiol Vaginal Gel (0.03 mg estradiol / g )
Drug: Estradiol Vaginal Gel
Daily for 14 days followed by 3 times per week for 10 weeks
Other Name: WC3011
Sham Comparator: Vehicle
Vehicle Vaginal Gel
Drug: Vehicle
Daily for 14 days followed by 3 times per week for 10 weeks
Other Name: Vehicle Vaginal Gel

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sexually active with self-identified dyspareunia (pain with sexual activity), at least moderate to severe & most bothersome symptom of VVA (vulvovaginal atrophy)
  • Postmenopausal & meets 1 of the following: 12 months spontaneous amenorrhea, 6 months spontaneous amenorrhea with FSH (follicle stimulating hormone) >40 mIU/mL,6 weeks postsurgical bilateral oophorectomy with confirmation by FSH >40 mIU/mL, surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure confirmed by FSH >40 mIU/mL
  • Age ≥40 years; ≥35 with bilateral oophorectomy
  • Normal clinical breast exam or negative mammogram if ≥ 40 years of age
  • Negative urine pregnancy test (non-hysterectomized & <12 months amenorrhea

Exclusion Criteria:

  • Enrollment Sponsor's Study PR-04409 or PR-05812
  • Participation in clinical trial or use of investigational drug within 30 days prior to screening
  • Known hypersensitivity to estrogen &/or progestin therapy
  • Known or suspected premalignant or malignant disease or history steroid-dependent malignancy
  • Manifestation or treatment for significant cardiovascular disease (congestive heart failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass, percutaneous angioplasty or > 50% angiographic narrowing of coronary artery
  • Thrombophlebitis or thromboembolic disorder or history of
  • Insulin-dependent diabetes mellitus
  • Increased frequency or severity of headaches while on hormone or estrogen therapy
  • Currently taking St. John's Wort
  • Drug/alcohol addiction within past 2 years
  • Treatment with anticoagulants (heparin or warfarin)
  • Smoking ≥15 cigarettes/day
  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: NCT01845649

  Show 55 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Warner Chilcott
  More Information

Additional Information:
No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01845649     History of Changes
Other Study ID Numbers: PR-08112
Study First Received: April 25, 2013
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
Vulvovaginal Atrophy
Dyspareunia
Postmenopausal

Additional relevant MeSH terms:
Dyspareunia
Atrophy
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Pathological Conditions, Anatomical
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 15, 2014