Efficacy and Tolerability of Angeliq in Thai Women - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185328

Purpose

To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.

Condition	Intervention	Phase
Postmenopause	Drug: Estradiol/DRSP (Angeliq, BAY86-4891)	Phase IV

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles

Further study details as provided by Bayer:

Primary Outcome Measures:

The relative change in the frequency of hot flushes [ Time Frame: At baseline, week 4, 8, 12 ]

Secondary Outcome Measures:

The change in intensity of hot flushes [ Time Frame: At baseline, week 4, 8, 12 ]
The relative change in frequency of hot flushes [ Time Frame: At baseline, week 4, 8 ]
The change in intensity of hot flushes [ Time Frame: At baseline, week 4, 8 ]
The proportions of subjects with urogenital symptoms [ Time Frame: At baseline, week 4, 8, 12 ]
Bleeding pattern [ Time Frame: At baseline, week 4, 8, 12 ]
Adverse events collection [ Time Frame: Collection of AE throughout the study period ]

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Estradiol/DRSP (Angeliq, BAY86-4891) 1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185328

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Responsible Party:	Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	91436, 309367
Study First Received:	September 12, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00185328
Health Authority:	Thailand: Food and Drug Administration

Keywords provided by Bayer:

Postmenopause

Study placed in the following topic categories:

Estradiol 3-benzoate
Estradiol valerate
Drospirenone

Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009