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

Sponsor:	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

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:	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

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 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 ]

Enrollment:	55
Study Start Date:	September 2005
Study Completion Date:	December 2006

Arms	Assigned Interventions
Experimental: Arm 1	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

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women with hot flushes

Exclusion Criteria:

Women with a contraindication for Hormone Replacement Therapy (HRT)

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

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

Keywords provided by Bayer:

Postmenopause

Additional relevant MeSH terms:

Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Drospirenone and ethinyl estradiol combination
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 09, 2012