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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

April 23, 2007
March 19, 2012
August 1994
November 1995   (final data collection date for primary outcome measure)
Relief of vaginal symptoms [ Time Frame: following 12 weeks of treatment. ] [ Designated as safety issue: No ]
Relief of vaginal symptoms following 12 weeks of treatment.
Complete list of historical versions of study NCT00465192 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Adverse Events, hematology and chemistry tests, and endometrial biopsy.
  • Vaginal and urethral cytology, and grading of vaginal health.
Not Provided
Not Provided
 
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Menopause
  • Postmenopausal Vaginal Atrophy
  • Drug: estradiol, 10 mcg
  • Drug: estradiol, 25 mcg
  • Drug: placebo
Not Provided
Bachmann G, Lobo RA, Gut R, Nachtigall L, Notelovitz M. Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):67-76.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
November 1995
November 1995   (final data collection date for primary outcome measure)

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
Female
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00465192
VAG/PD/009/USA
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Jan Öhrström, MD Novo Nordisk
Novo Nordisk
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP