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Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00465192
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 for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.


Condition Intervention Phase
Menopause
Postmenopausal Vaginal Atrophy
 Drug: estradiol, 10 mcg
Drug: estradiol, 25 mcg
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses 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: following 12 weeks of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: No ]
  • Hematology and chemisty tests, and endometrial biopsy [ Designated as safety issue: No ]
  • Vaginal and urethral cytology, and grading of vaginal health [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: August 1994
Study Completion Date: November 1995
Primary Completion Date: November 1995 (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

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
  • Vaginal infection
  • Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
  • Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
  • History of treatment with diethylstilbestrol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465192

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: NCT00465192     History of Changes
Other Study ID Numbers: VAG/PD/009/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 19, 2013