Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis - Full Text View

Sponsor:	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: estradiol, 10 mcg Drug: estradiol, 25 mcg Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Relief of vaginal symptoms [ Time Frame: following 12 weeks of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Designated as safety issue: No ]
Hematology and chemisty tests, and endometrial biopsy [ Designated as safety issue: No ]
Vaginal and urethral cytology, and grading of vaginal health [ Designated as safety issue: No ]

Estimated Enrollment:	230
Study Start Date:	August 1994
Study Completion Date:	November 1995
Primary Completion Date:	November 1995 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Generally healthy
Postmenopausal
Hysterectomized or non-hysterectomized
Moderate or severe vaginal dryness and soreness

Exclusion Criteria:

Known, suspected, or past history of breast cancer
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
Vaginal infection
Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
History of treatment with diethylstilbestrol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465192

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Jan Öhrström, MD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00465192 History of Changes
Other Study ID Numbers:	VAG/PD/009/USA
Study First Received:	April 23, 2007
Last Updated:	November 18, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vaginitis
Atrophy
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
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 February 12, 2012