Study 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

Inclusion Criteria
- Postmenopausal Korean women suffering from hot flushes
Exclusion Criteria
- 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

Trial Dates

July 2004 - May 2005

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Angeliq (E2/DRSP, BAY86-4891)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Seoul National University Hospital	Seoul, 110-744, Korea, Republic Of
Completed	Samsung Medical Center	Seoul, 135-710, Korea, Republic Of
Completed	Inje University Sanggye Paik Hospital	Seoul, Korea, Republic Of
Terminated	Asan Medical Center	Seoul, 138-736, Korea, Republic Of
Completed	Chung-Ang University Yongsan Hospital	Seoul, Korea, Republic Of
Completed	Gangnam Severance Hospital, Yonsei University	Seoul, Korea, Republic Of

Primary Outcome

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

Secondary Outcome

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

Additional Information

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