Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-day Treatment Cycles.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00356447

Enrollment

249

Registered

2006-07-26

Start date

2006-05-31

Completion date

2007-10-31

Last updated

2014-10-01

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

Conditions

Vasomotor Symptoms

Brief summary

The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

Detailed description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Interventions

DRUGEstradiol/DRSP (Angeliq, BAY86-4891)

Drospirenone (DRSP) 2mg and Estradiol 1mg. One cycle consists of 28 days. One tablet daily for 28 days given for a total of 4 cycles. Oral administration.

DRUGPlacebo

Same administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Chinese postmenopausal women with moderate to severe vasomotor symptoms

Exclusion criteria

* History of steroid hormone dependent malignant disease * Known or suspected malignant or premalignant disease * Current or history of severe heart, liver, renal, psychiatric disease * Hyperlipemia

Design outcomes

Primary

Measure	Time frame
Frequency of hot flushes	From baseline to week 16
Change in intensity of hot flushes	From baseline to week 16

Secondary

Measure	Time frame
Change in other climacteric symptoms	From baseline to week 16
Vaginal Bleeding pattern	From baseline to week 16
Global clinical impression	From baseline to week 16

Countries

China

Outcome results

None listed

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