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| Sponsored by: |
Novo Nordisk |
|---|---|
| Information provided by: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT00465192 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrophic Vaginitis |
Drug: 17-Beta Estradiol, 10 micrograms Drug: 17-Beta Estradiol, 25 micrograms |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 230 |
| Study Start Date: | August 1994 |
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
| Study ID Numbers: | VAG/PD/009/USA |
| Study First Received: | April 23, 2007 |
| Last Updated: | December 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00465192 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pathological Conditions, Anatomical Estrogens Contraceptive Agents Benzoates Hormone Antagonists Vaginitis Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists |
Vaginal Diseases Estradiol 17 beta-cypionate Hormones Estradiol Genital Diseases, Female Estradiol 3-benzoate Atrophy Polyestradiol phosphate |
|
Pathological Conditions, Anatomical Estrogens Contraceptive Agents Physiological Effects of Drugs Vaginitis Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Vaginal Diseases Reproductive Control Agents |
Estradiol 17 beta-cypionate Hormones Pharmacologic Actions Estradiol Genital Diseases, Female Therapeutic Uses Estradiol 3-benzoate Atrophy Polyestradiol phosphate |