Evaluate Long-Term Safety and Efficacy WC3011

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01455597
First received: October 17, 2011
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Vulvovaginal Atrophy
Drug: Estradiol Vaginal Gel
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Number of Subjects without Endometrial Hyperplasia or Worse at Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Subject's Self-Assessment of Intensity of Vaginal Dryness from Baseline to Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ] [ Designated as safety issue: No ]
  • Change in Vaginal Cytology (Maturation Index) from Baseline to Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ] [ Designated as safety issue: No ]
  • Change in Vaginal pH from Baseline to Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ] [ Designated as safety issue: No ]
  • Change in Investigator Assessment of Vulvovaginal Atrophy (VVA) from Baseline to Visit 7/Final Visit [ Time Frame: Week 40/Final Visit ] [ Designated as safety issue: No ]

Enrollment: 309
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT01455597

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

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01455597     History of Changes
Other Study ID Numbers: PR-04509
Study First Received: October 17, 2011
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Atrophy
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 August 01, 2014