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

Primary Purpose

Menopause, Postmenopausal Vaginal Atrophy

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
estradiol, 25 mcg
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Relief of vaginal symptoms
    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

    Full Information

    First Posted
    April 23, 2007
    Last Updated
    February 28, 2017
    Sponsor
    Novo Nordisk A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00464971
    Brief Title
    Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial
    Official Title
    Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 31, 1995 (Actual)
    Primary Completion Date
    November 30, 1996 (Actual)
    Study Completion Date
    November 30, 1996 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novo Nordisk A/S

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menopause, Postmenopausal Vaginal Atrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    estradiol, 25 mcg
    Primary Outcome Measure Information:
    Title
    Relief of vaginal symptoms
    Time Frame
    over 12 months of treatment
    Title
    Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels
    Secondary Outcome Measure Information:
    Title
    Vaginal health, vaginal cytology and urethral cytology

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Global Clinical Registry (GCR, 1452)
    Organizational Affiliation
    Novo Nordisk A/S
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18165394
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://novonordisk-trials.com
    Description
    Clinical Trials at Novo Nordisk

    Learn more about this trial

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

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