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Efficacy and Tolerability of Angeliq in Thai Women

NCT ID: NCT00185328

Last Updated: 2008-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Conditions

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Postmenopause

Keywords

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Postmenopause

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Estradiol/DRSP (Angeliq, BAY86-4891)

Intervention Type DRUG

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

Interventions

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Estradiol/DRSP (Angeliq, BAY86-4891)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women with hot flushes

Exclusion Criteria

* Women with a contraindication for Hormone Replacement Therapy (HRT)
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Schering Pharma AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Countries

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Thailand

Other Identifiers

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309367

Identifier Type: -

Identifier Source: secondary_id

91436

Identifier Type: -

Identifier Source: org_study_id