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OpenTrials
Completed

NCT Number: NCT00465192

Efficacy and Safety of 17-Beta Estradiol in Treatment of 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.

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Key information

Conditions

Menopause Postmenopausal Vaginal Atrophy

Age range

45 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

estradiol, 10 mcg

Drug

estradiol, 25 mcg

Drug

Placebo

Drug

Primary outcomes

  1. Relief of vaginal symptoms

    Time frame: following 12 weeks of treatment.

Secondary outcomes

  1. Adverse events

  2. Hematology and chemisty tests, and endometrial biopsy

  3. Vaginal and urethral cytology, and grading of vaginal health

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
1994
Primary completion
1995
Study completion
1995
First posted
Apr 24, 2007
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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