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Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00464971
First received: April 23, 2007
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.


Condition Intervention Phase
Menopause
Postmenopausal Vaginal Atrophy
 Drug: estradiol, 25 mcg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Relief of vaginal symptoms [ Time Frame: over 12 months of treatment ] [ Designated as safety issue: No ]
  • Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaginal health, vaginal cytology and urethral cytology [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: January 1995
Study Completion Date: November 1996
Primary Completion Date: November 1996 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Generally healthy
  • Postmenopausal
  • Hysterectomized or non-hysterectomized
  • Moderate or severe vaginal dryness and soreness
  • Successful completion of the study VAG/PD/009/USA

Exclusion Criteria:

  • Known, suspected, or past history of breast cancer
  • Known, suspected, or past history of hormone-dependent tumor
  • Genital bleeding of unknown etiology
  • Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
  • Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
  • Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464971

Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jan Öhrström, MD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00464971     History of Changes
Other Study ID Numbers: VAG/PD/012/USA
Study First Received: April 23, 2007
Last Updated: March 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vaginitis
Atrophy
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
 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 May 21, 2013