Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Primary Purpose
Menopause, Postmenopausal Vaginal Atrophy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
estradiol, 10 mcg
estradiol, 25 mcg
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Menopause
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Relief of vaginal symptoms
Secondary Outcome Measures
Adverse events
Hematology and chemisty tests, and endometrial biopsy
Vaginal and urethral cytology, and grading of vaginal health
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00465192
Brief Title
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 31, 1994 (Actual)
Primary Completion Date
November 30, 1995 (Actual)
Study Completion Date
November 30, 1995 (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 for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
estradiol, 10 mcg
Intervention Type
Drug
Intervention Name(s)
estradiol, 25 mcg
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Relief of vaginal symptoms
Time Frame
following 12 weeks of treatment.
Secondary Outcome Measure Information:
Title
Adverse events
Title
Hematology and chemisty tests, and endometrial biopsy
Title
Vaginal and urethral cytology, and grading of vaginal health
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
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
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
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
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