Efficacy and Tolerability of Angeliq in Thai Women

A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185328

Enrollment

Registered

2005-09-16

Start date

2005-09-30

Completion date

2006-12-31

Last updated

2008-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopause

Keywords

Postmenopause

Brief summary

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

Detailed description

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.

Interventions

DRUGEstradiol/DRSP (Angeliq, BAY86-4891)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Postmenopausal women with hot flushes

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The relative change in the frequency of hot flushes	At baseline, week 4, 8, 12

Secondary

Measure	Time frame
The relative change in frequency 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
Adverse events collection	Collection of AE throughout the study period
The change in intensity of hot flushes	At baseline, week 4, 8, 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026