Efficacy and Tolerability of Angeliq in Thai Women

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Postmenopause	Drug: Estradiol/DRSP (Angeliq, BAY86-4891) Other Names	Phase 4

Tracking Information

First Submitted Date	September 12, 2005
Last Update Posted Date	December 11, 2008
Start Date	September 01, 2005
Actual Completion Date	December 01, 2006
Primary Completion Date	N/A
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Current 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]

Original Secondary Outcome Measures

Study Design

Brief Title	Efficacy and Tolerability of Angeliq in Thai Women
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
Brief Summary	To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.
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.
Study Type	Interventional
Study Phase	Phase 4
Estimated Enrollment	55
Allocation	Non-Randomized
Interventional Model	Single Group Assignment
Masking	None
Primary Purpose	Treatment
Conditions	Postmenopause
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	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 Other Names
Study Groups/Cohorts	Arm 1
Study Arms	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

Arm	Intervention/Treatment
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

Recruitment Information

Recruitment Status:	Completed
Enrollment	55
Completion Date	December 01, 2006
Eligibility Criteria:	Inclusion Criteria: - Postmenopausal women with hot flushes Exclusion Criteria: - Women with a contraindication for Hormone Replacement Therapy (HRT)
Gender	Female
Age	45 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Thailand

Administrative Information

NCT Number:	NCT00185328
Other Study ID Numbers	91436 309367
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	Medical Affairs Therapeutic Area Head,
Study Sponsor	Bayer
Collaborators	Not Available
Investigators	Study Director Bayer Study Director Bayer