NCT00651599

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

First QC Date

April 1, 2008

Last Update Submit

December 30, 2014

Conditions

Vasomotor Symptoms

Keywords

Vasomotor symptomsVasomotor System

Outcome Measures

Primary Outcomes (1)

  • Hot flush (frequency and severity)

    Daily in pre-treatment and treatment period

Secondary Outcomes (3)

  • Menopausal symptoms

    Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment

  • Urogenital symptoms

    Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment

  • Assessment of bleeding

    daily in pre-treatment and treatment period

Study Arms (2)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Arm 1

EXPERIMENTAL
Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Interventions

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)DRUG

Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

Arm 1
PlaceboDRUG

Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.

Arm 2

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal Korean women suffering from hot flushes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 135-710, South Korea

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Interventions

estradiol-drospirenone combination

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 3, 2008

Study Start

July 1, 2004

Study Completion

May 1, 2005

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

KR(4)