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

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.
 
ClinicalTrials.gov Identifier: NCT00465192
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE April 23, 2007
First Posted Date  ICMJE April 24, 2007
Last Update Posted Date March 1, 2017
Actual Study Start Date  ICMJE August 31, 1994
Actual Primary Completion Date November 30, 1995   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
Relief of vaginal symptoms [ Time Frame: following 12 weeks of treatment. ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2007)
Relief of vaginal symptoms following 12 weeks of treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
  • Adverse events
  • Hematology and chemisty tests, and endometrial biopsy
  • Vaginal and urethral cytology, and grading of vaginal health
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2007)
  • Adverse Events, hematology and chemistry tests, and endometrial biopsy.
  • Vaginal and urethral cytology, and grading of vaginal health.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Menopause
  • Postmenopausal Vaginal Atrophy
Intervention  ICMJE
  • Drug: estradiol, 10 mcg
  • Drug: estradiol, 25 mcg
  • Drug: placebo
Study Arms  ICMJE Not Provided
Publications * 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. doi: 10.1097/01.AOG.0000296714.12226.0f.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 23, 2007)
230
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 1995
Actual Primary Completion Date November 30, 1995   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00465192
Other Study ID Numbers  ICMJE VAG/PD/009/USA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2017

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