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NCT00185328 Clinical Trial

Efficacy and Tolerability of Angeliq in Thai Women

Postmenopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00185328
Other study ID # 91436
Secondary ID 309367
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated December 11, 2008
Start date September 2005
Est. completion date December 2006

Study information
Verified date December 2008
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Thailand: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 45 Years and older
Eligibility Inclusion Criteria:

- Postmenopausal women with hot flushes

Exclusion Criteria:

- Women with a contraindication for Hormone Replacement Therapy (HRT)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Outcome
Type Measure Description Time frame Safety issue
Primary The relative change in the frequency of hot flushes At baseline, week 4, 8, 12
Secondary The change in intensity of hot flushes At baseline, week 4, 8, 12
Secondary The relative change in frequency of hot flushes At baseline, week 4, 8
Secondary The change in intensity of hot flushes At baseline, week 4, 8
Secondary The proportions of subjects with urogenital symptoms At baseline, week 4, 8, 12
Secondary Bleeding pattern At baseline, week 4, 8, 12
Secondary Adverse events collection Collection of AE throughout the study period
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