Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00431132
First received: February 2, 2007
Last updated: May 13, 2016
Last verified: May 2016
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Purpose
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Menopause Postmenopausal Vaginal Atrophy |
Drug: estradiol, 10 mcg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies [ Time Frame: Week 52 ] [ Designated as safety issue: No ]The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.
Secondary Outcome Measures:
- Transvaginal Ultrasound: Endometrial Thickness [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.
| Enrollment: | 336 |
| Study Start Date: | January 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vagifem® 10 mcg
One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
|
Drug: estradiol, 10 mcg
Tablets, administered intravaginally twice weekly
|
Eligibility| Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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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: NCT00431132
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431132
Locations
| Czech Republic | |
| Prague 5, Czech Republic, 150 00 | |
| Denmark | |
| Glostrup, Denmark, 2600 | |
| Finland | |
| Turku, Finland, 20100 | |
| France | |
| Paris, France, 75015 | |
| Hungary | |
| Budapest, Hungary, H-1088 | |
| Norway | |
| Trondheim, Norway, NO-7012 | |
| Sweden | |
| Uppsala, Sweden, 751 85 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00431132 History of Changes |
| Other Study ID Numbers: | VAG-1748 2006-001629-24 |
| Study First Received: | February 2, 2007 |
| Results First Received: | February 7, 2011 |
| Last Updated: | May 13, 2016 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Denmark: Danish Medicines Agency Hungary: National Institute of Pharmacy Finland: Finnish Medicines Agency Czech Republic: State Institute for Drug Control Norway: Norwegian Medicines Agency Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Atrophy Vaginitis Atrophic Vaginitis Pathological Conditions, Anatomical Vaginal Diseases Genital Diseases, Female Estradiol Polyestradiol phosphate Estradiol 3-benzoate |
Estradiol 17 beta-cypionate Estradiol valerate Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on September 23, 2016