Efficacy and Tolerability of Angeliq in Thai Women

Bayer55 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postmenopause

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

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal women with hot flushes Exclusion Criteria: * Women with a contraindication for Hormone Replacement Therapy (HRT)

Outcomes

Primary Outcomes

The relative change in the frequency of hot flushes

Time frame: At baseline, week 4, 8, 12

Secondary Outcomes

The change in intensity of hot flushes

Time frame: At baseline, week 4, 8, 12

The relative change in frequency of hot flushes

Time frame: At baseline, week 4, 8

The change in intensity of hot flushes

Time frame: At baseline, week 4, 8

The proportions of subjects with urogenital symptoms

Time frame: At baseline, week 4, 8, 12

Bleeding pattern

Time frame: At baseline, week 4, 8, 12

Adverse events collection

Time frame: Collection of AE throughout the study period

Data from ClinicalTrials.gov

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