Efficacy and Tolerability of Angeliq in Thai Women

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00185328

First received: September 12, 2005

Last updated: December 11, 2008

Last verified: December 2008

History of Changes

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 4


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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on March 03, 2015

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