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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.
Information provided by:
Novo Nordisk A/S Identifier:
First received: April 23, 2007
Last updated: March 19, 2012
Last verified: March 2012
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
Postmenopausal Vaginal Atrophy
Drug: estradiol, 25 mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Relief of vaginal symptoms [ Time Frame: over 12 months of treatment ]
  • Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels

Secondary Outcome Measures:
  • Vaginal health, vaginal cytology and urethral cytology

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)

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00464971

Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Jan Öhrström, MD Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00464971     History of Changes
Other Study ID Numbers: VAG/PD/012/USA 
Study First Received: April 23, 2007
Last Updated: March 19, 2012

Additional relevant MeSH terms:
Atrophic Vaginitis
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female processed this record on February 20, 2017