Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial
NCT ID: NCT00464971
Last Updated: 2017-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
102 participants
INTERVENTIONAL
1995-01-31
1996-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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estradiol, 25 mcg
Eligibility Criteria
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Inclusion Criteria
* 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 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
45 Years
80 Years
FEMALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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VAG/PD/012/USA
Identifier Type: -
Identifier Source: org_study_id
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