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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00431132 |
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Date of registration:
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02/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
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Scientific title:
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A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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336 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00431132 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Czech Republic
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Denmark
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Finland
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France
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Hungary
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Norway
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Sweden
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Postmenopausal women whose last menstruation was at least two years prior to the time
of screening
- At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar
irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding
associated with sexual activity
- Generally healthy
Exclusion Criteria:
- Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone
replacement therapy) within past 3 months
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Menopause
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Postmenopausal Vaginal Atrophy
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Intervention(s)
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Drug: estradiol, 10 mcg
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Primary Outcome(s)
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Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
[Time Frame: Week 52]
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Secondary Outcome(s)
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Transvaginal Ultrasound: Endometrial Thickness
[Time Frame: Week 0, week 52]
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Secondary ID(s)
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VAG-1748
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2006-001629-24
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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