check_circleStudy Completed

Postmenopause

Bayer Identifier:
91436
ClinicalTrials.gov Identifier:
NCT00185328
EudraCT Number:
Not Available
EU CT Number:
Not Available
Efficacy and Tolerability of Angeliq in Thai women

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

45 Years
  • - Postmenopausal women with hot flushes
  • - Women with a contraindication for Hormone Replacement Therapy (HRT)

Trial summary

Enrollment Goal
55
Trial Dates
September 2005 - December 2006
Phase
Phase 4
Could I Receive a placebo
No
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteer
No

Primary Outcome

  • The relative change in the frequency of hot flushes
    date_rangeTime Frame:
    At baseline, week 4, 8, 12
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • The change in intensity of hot flushes
    date_rangeTime Frame:
    At baseline, week 4, 8, 12
    enhanced_encryption
    Safety Issue:
    None
  • The relative change in frequency of hot flushes
    date_rangeTime Frame:
    At baseline, week 4, 8
    enhanced_encryption
    Safety Issue:
    None
  • The change in intensity of hot flushes
    date_rangeTime Frame:
    At baseline, week 4, 8
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    Safety Issue:
    None
  • The proportions of subjects with urogenital symptoms
    date_rangeTime Frame:
    At baseline, week 4, 8, 12
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    Safety Issue:
    None
  • Bleeding pattern
    date_rangeTime Frame:
    At baseline, week 4, 8, 12
    enhanced_encryption
    Safety Issue:
    None
  • Adverse events collection
    date_rangeTime Frame:
    Collection of AE throughout the study period
    enhanced_encryption
    Safety Issue:
    None

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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