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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01845649
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Vulvovaginal Atrophy Drug: Estradiol Vaginal Gel Drug: Vehicle Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : April 2013
Primary Completion Date : November 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Estradiol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in Intensity of Dyspareunia, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]
  2. Change in Maturation Index [ Time Frame: Baseline and Week 12 ]
    Vaginal wall smear; Maturation Index = 0.2 x parabasal + 0.6 x intermediate + 1.0 x superficial

  3. Change in Vaginal pH [ Time Frame: Baseline and Week 12 ]

Secondary Outcome Measures :
  1. Change in Vaginal and/or Vulvar Irritation/Itching, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]
  2. Change in Dysuria (painful or difficult urination), Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]
  3. Change in Vaginal Bleeding Associated with Sexual Activity, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]
  4. Change in Vaginal Dryness, Subject Self-Assessment [ Time Frame: Baseline and Week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845649


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

Additional Information:
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01845649     History of Changes
Other Study ID Numbers: PR-08112
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: February 2015

Keywords provided by Warner Chilcott:
Vulvovaginal Atrophy
Dyspareunia
Postmenopausal

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