Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms - Full Text View

Sponsor:	KV Pharmaceutical Company
Information provided by:	KV Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT01389102

Purpose

Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.

Condition	Intervention	Phase
Hot Flashes	Drug: Estradiol transdermal one 90 μL spray Drug: Estradiol transdermal spray, two 90 μL sprays Drug: Estradiol transdermal three 90 μL sprays Drug: Placebo transdermal two 90 μL sprays Drug: Placebo transdermal three 90 μL sprays Drug: Placebo transdermal one 90 μL spray	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 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women

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 KV Pharmaceutical Company:

Primary Outcome Measures:

Mean change in severity of moderate to severe vasomotor symptoms [ Time Frame: baseline to week 12 (12 weeks) ] [ Designated as safety issue: No ]
Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms [hot flushes and sweating] experienced each day.

Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity
Mean change in severity of moderate to severe vasomotor symptoms [ Time Frame: baseline to week 12 (12 weeks) ] [ Designated as safety issue: No ]
Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms [hot flushes and sweating] experienced each day.

Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity

The severity of moderate to severe hot flushes was calculated using the severity score of moderate to severe hot flushes:

(2 x # moderate + 3 x # severe) / (# moderate + # severe)

Enrollment:	458
Study Start Date:	December 2004
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo transdermal three 90 μL sprays Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Drug: Placebo transdermal three 90 μL sprays Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
Placebo Comparator: Placebo transdermal two 90 μL sprays Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Drug: Placebo transdermal two 90 μL sprays Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
Placebo Comparator: Placebo transdermal one 90 μL spray Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Drug: Placebo transdermal one 90 μL spray Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Active Comparator: Estradiol transdermal three 90 μL sprays Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Drug: Estradiol transdermal three 90 μL sprays Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
Active Comparator: Estradiol transdermal two 90 μL sprays Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator	Drug: Estradiol transdermal spray, two 90 μL sprays Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
Active Comparator: Estradiol transdermal one 90 μL spray Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator	Drug: Estradiol transdermal one 90 μL spray Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

Detailed Description:

Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Post menopausal women,
Ages 35 or older,
Frequent moderate to severe hot flushes,
Qualifying general medical health

Exclusion Criteria:

Disqualifying gynecological disorders,
Disqualifying dermatological disorders,
Disqualifying concurrent conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389102

Show 43 Study Locations

Sponsors and Collaborators

KV Pharmaceutical Company

More Information

No publications provided by KV Pharmaceutical Company

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

Buster JE, Koltun WD, Pascual ML, Day WW, Peterson C. Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1343-51.

Responsible Party:	Jim Joffrion, Senior Director Clinical Affairs, KV Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT01389102 History of Changes
Obsolete Identifiers:	NCT00122200
Other Study ID Numbers:	EST-01
Study First Received:	July 5, 2011
Last Updated:	July 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by KV Pharmaceutical Company:

Postmenopause
Hot Flashes
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate

Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes
Hormone Antagonists

Additional relevant MeSH terms:

Hot Flashes
Signs and Symptoms
Estradiol 17 beta-cypionate
Estradiol valerate
Estradiol 3-benzoate
Estradiol
Polyestradiol phosphate
Hormone Antagonists
Contraceptive Agents, Female

Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 12, 2012