Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

This study has been completed.

First Received on April 23, 2007. Last Updated on November 18, 2011 History of Changes

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00464971

Purpose

This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.

Condition	Intervention	Phase
Atrophic Vaginitis	Drug: estradiol, 25 mcg	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Safety and Efficacy of 17-Beta Estradiol 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: over 12 months of treatment ] [ Designated as safety issue: No ]
Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vaginal health, vaginal cytology and urethral cytology [ Designated as safety issue: No ]

Estimated Enrollment:	102
Study Start Date:	January 1995
Study Completion Date:	November 1996
Primary Completion Date:	November 1996 (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
Successful completion of the study VAG/PD/009/USA

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
Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464971

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:	NCT00464971 History of Changes
Other Study ID Numbers:	VAG/PD/012/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