Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00431132
First received: February 2, 2007
Last updated: March 19, 2012
Last verified: March 2012
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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:
MedlinePlus related topics:
Menopause
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:
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431132
Locations
| Czech Republic | |
| Prague, Czech Republic | |
| Denmark | |
| Glostrup, Denmark, 2600 | |
| Finland | |
| Turku, Finland, 20100 | |
| France | |
| Paris, France, 75015 | |
| Hungary | |
| Budapest, Hungary | |
| Norway | |
| Trondheim, Norway, NO-7012 | |
| Sweden | |
| Uppsala, Sweden | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Michaela Eugster-Hausmann, MD | Novo Nordisk FemCare AG |
More Information
Additional Information:
No publications provided by Novo Nordisk
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Public Access to Clinical Trials, 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: | March 19, 2012 |
| 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:
|
Vaginitis Atrophy Adenoma Vaginal Diseases Genital Diseases, Female Pathological Conditions, Anatomical Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Estradiol Polyestradiol phosphate Estradiol valerate |
Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on June 18, 2013