NCT00185328

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 12, 2008

Status Verified

December 1, 2008

First QC Date

September 12, 2005

Last Update Submit

December 11, 2008

Conditions

Postmenopause

Keywords

Postmenopause

Outcome Measures

Primary Outcomes (1)

  • The relative change in the frequency of hot flushes

    At baseline, week 4, 8, 12

Secondary Outcomes (6)

  • The change in intensity of hot flushes

    At baseline, week 4, 8, 12

  • The relative change in frequency of hot flushes

    At baseline, week 4, 8

  • The change in intensity of hot flushes

    At baseline, week 4, 8

  • The proportions of subjects with urogenital symptoms

    At baseline, week 4, 8, 12

  • Bleeding pattern

    At baseline, week 4, 8, 12

  • +1 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Estradiol/DRSP (Angeliq, BAY86-4891)

Interventions

Estradiol/DRSP (Angeliq, BAY86-4891)DRUG

1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Postmenopausal women with hot flushes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

estradiol-drospirenone combination

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

September 1, 2005

Study Completion

December 1, 2006

Last Updated

December 12, 2008

Record last verified: 2008-12