check_circleStudy Completed

Vasomotor Symptoms

Bayer Identifier:

91354

ClinicalTrials.gov Identifier:

NCT00651599

EudraCT Number:

Not Available

EU CT Number:

Not Available
Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

Trial purpose

Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.

Key Participants Requirements

Sex

Female

Age

45 - 65 Years
  • - Postmenopausal Korean women suffering from hot flushes
  • - Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.

Trial summary

Enrollment Goal
90
Trial Dates
July 2004 - May 2005
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Inje University Sanggye Paik HospitalSeoul, Korea, Republic Of
Terminated
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Chung-Ang University Yongsan HospitalSeoul, Korea, Republic Of
Completed
Gangnam Severance Hospital, Yonsei UniversitySeoul, Korea, Republic Of

Primary Outcome

  • Hot flush (frequency and severity)
    date_rangeTime Frame:
    Daily in pre-treatment and treatment period
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Menopausal symptoms
    date_rangeTime Frame:
    Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Urogenital symptoms
    date_rangeTime Frame:
    Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
    enhanced_encryption
    Safety Issue:
    no
  • Assessment of bleeding
    date_rangeTime Frame:
    daily in pre-treatment and treatment period
    enhanced_encryption
    Safety Issue:
    no

Trial design

A double-blind, randomized, placebo-controlled, multicenter study investigating the efficacy and tolerability of Angeliq(drospirenon2mg and estradiol 1mg) in postmenopausal Korean women with vasomotor symptoms over 3, 28 day treatment cycle
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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