Trial record 13 of 56 for:    Vaginitis: Clinical Trials

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

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 for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.

Condition Intervention Phase
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:

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

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)

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT00465192

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

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S 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:
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female processed this record on April 17, 2014