Low-dose Hormone Therapy for Relief of Vasomotor Symptoms - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00446199

Purpose

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Condition	Intervention	Phase
Vasomotor Symptoms Hot Flushes	Drug: Placebo (SH T546P) Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891, SH T04739BA) Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891, SH T04739CA) Drug: Estradiol (E2 0.3mg) (SH T04739DA)	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 Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen 1,2-Dihydrospirorenone Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Mean change from baseline to Week 12 in weekly frequency of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 12 in weekly mean daily severity of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 4 in weekly frequency of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 4 in weekly mean daily severity of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change from baseline to Week 12 in vaginal pH and vaginal maturation index [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Symptoms of vulvar and vaginal atrophy and urogenital symptoms at baseline and Week 12 [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]

Enrollment:	735
Study Start Date:	March 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891, SH T04739BA) One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Experimental: Arm 2	Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891, SH T04739CA) One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Experimental: Arm 3	Drug: Estradiol (E2 0.3mg) (SH T04739DA) One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
Placebo Comparator: Arm 4	Drug: Placebo (SH T546P) Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Detailed Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week

Exclusion Criteria:

The usual exclusion criteria for hormone therapy apply
Intake of medications other than hormones affecting hot flushes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446199

Show 75 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00446199 History of Changes
Other Study ID Numbers:	91493, 310184
Study First Received:	March 9, 2007
Last Updated:	May 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Vasomotor symptom relief
Postmenopausal women
Severe to Moderate Vasomotor symptoms

Additional relevant MeSH terms:

Hot Flashes
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Drospirenone
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
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012