Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00464971
First received: April 23, 2007
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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
Menopause
Postmenopausal Vaginal Atrophy
Drug: estradiol, 25 mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaginal health, vaginal cytology and urethral cytology [ Designated as safety issue: No ]

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)
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464971

Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00464971     History of Changes
Other Study ID Numbers: VAG/PD/012/USA
Study First Received: April 23, 2007
Last Updated: March 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrophic Vaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 22, 2014