Evaluate Long-Term Safety and Efficacy WC3011

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. Identifier: NCT01455597
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Warner Chilcott

Brief Summary:
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.

Condition or disease Intervention/treatment Phase
Vulvovaginal Atrophy Drug: Estradiol Vaginal Gel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of WC3011 in the Treatment of Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
Study Start Date : October 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Estradiol Vaginal Gel
WC3011 Estradiol Vaginal Gel, administered 3X weekly for 40 weeks
Drug: Estradiol Vaginal Gel
Estradiol vaginal gel containing 0.017 mg estradiol per gram, 3X weekly for 40 weeks
Other Name: WC3011

Primary Outcome Measures :
  1. Number of Subjects without Endometrial Hyperplasia or Worse at Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ]

Secondary Outcome Measures :
  1. Change in Subject's Self-Assessment of Intensity of Vaginal Dryness from Baseline to Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ]
  2. Change in Vaginal Cytology (Maturation Index) from Baseline to Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ]
  3. Change in Vaginal pH from Baseline to Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ]
  4. Change in Investigator Assessment of Vulvovaginal Atrophy (VVA) from Baseline to Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ]

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

Inclusion Criteria:

  • Completed Study PR-04409

Exclusion Criteria:

  • Developed any of the following during Study-PR04409 or has begun taking hormone therapy other than WC3011:
  • 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, stroke or ischemic attack
  • Insulin-dependent diabetes mellitus
  • Smoking ≥ 15 cigarettes daily
  • Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg

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 identifier (NCT number): NCT01455597

  Show 71 Study Locations
Sponsors and Collaborators
Warner Chilcott
Study Director: Herman Ellman, MD Warner Chilcott

Responsible Party: Warner Chilcott Identifier: NCT01455597     History of Changes
Other Study ID Numbers: PR-04509
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: February 2015

Keywords provided by Warner Chilcott:
Postmenopausal Women
Vaginal Dryness
Postmenopausal Vulvovaginal Atrophy

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female