Efficacy and Tolerability of Angeliq in Thai Women

ID: NCT00185328
Status: Completed
Phase: Phase 4
Start Date: September 01, 2005
First Submitted: September 12, 2005
Last Updated: December 11, 2008
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: N/A
Conditions: Postmenopause
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Study Description

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.
Condition or disease Intervention/treatment Phase

Postmenopause

Drug: Estradiol/DRSP (Angeliq, BAY86-4891)
Other Names
Phase 4

Tracking Information

First Submitted DateSeptember 12, 2005
Last Update Posted DateDecember 11, 2008
Start DateSeptember 01, 2005
Actual Completion DateDecember 01, 2006
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/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

Not Available

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

Not Available

Study Design

Brief TitleEfficacy and Tolerability of Angeliq in Thai Women
Official TitleA 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 TypeInterventional
Study PhasePhase 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 MethodN/A
Study PopulationN/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)

Recruitment Information

Recruitment Status:Completed
Enrollment55
Completion DateDecember 01, 2006
Eligibility Criteria: Inclusion Criteria:
- Postmenopausal women with hot flushes

Exclusion Criteria:
- Women with a contraindication for Hormone Replacement Therapy (HRT)
GenderFemale
Age45 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Thailand

Administrative Information

NCT Number:NCT00185328
Other Study ID Numbers
91436
309367
Has Data Monitoring CommitteeNo
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 PartyMedical Affairs Therapeutic Area Head,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer